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Clinical Specialist Resume Examples

Whether you are a seasoned clinical specialist or new to the profession, having a well-written resume is key to getting hired. Writing an effective resume requires a balance of showcasing your experience and skills in a professional manner while making it stand out from the competition. This guide will provide some tips for writing a standout clinical specialist resume with examples to get you started. By applying the tips and advice discussed, you will be well on your way to landing your dream job.

If you didn’t find what you were looking for, be sure to check out our complete library of resume examples .

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Clinical Specialist

123 Main Street | Anytown, USA 99999 | Phone: (123) 456-7890 | Email: [email protected]

I am a highly experienced Clinical Specialist with extensive expertise in both clinical and operational management. I am passionate about the provision of quality healthcare to all patients, as well as the efficient and effective running of a healthcare organisation. My core competencies include extensive knowledge of the principles and procedures of clinical practice, effective clinical supervision, excellent communication and interpersonal skills, and a strong commitment to evidence- based practice. I am confident in my ability to develop and implement best practices, resolve challenging issues and drive continuous improvement.

Core Skills :

  • Clinical practice knowledge
  • Clinical supervision
  • Operational management
  • Excellent communication and interpersonal skills
  • Evidence- based practice
  • Developing best practices
  • Problem solving
  • Continuous improvement

Professional Experience :

Clinical Specialist, ABC Hospital, 2020- present

  • Developed and implemented best practices for clinical practice in the hospital
  • Supervised and provided guidance to nurses, midwives and other healthcare professionals
  • Provided expert advice to senior management on clinical matters
  • Assisted with the management of patient records
  • Developed and implemented policies and procedures for the efficient running of the hospital

Clinical Supervisor, XYZ Clinic, 2018- 2020

  • Mentored and supported junior clinical staff
  • Developed and implemented policies and procedures for the efficient running of the clinic
  • Developed and implemented quality assurance processes to ensure the highest quality of clinical care
  • Monitored and evaluated patient outcomes

Education :

Doctor of Nursing Practice, ABC University, 2016- 2018 Bachelor of Nursing, XYZ University, 2013- 2016

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Clinical Specialist Resume with No Experience

Recent college graduate with a Bachelor’s degree in Health Science, looking for an entry- level Clinical Specialist role. Highly motivated and eager to learn, with a passion for helping others and providing the best care possible.

  • Knowledge of the human anatomy and medical terminology
  • Excellent written and verbal communication skills
  • Outstanding organizational and multitasking abilities
  • Proficient in Microsoft Office and medical software programs
  • Strong attention to detail and problem- solving skills
  • Ability to work independently and in a team- oriented environment

Responsibilities

  • Assist in providing patient care by aiding the medical team in various clinical procedures
  • Maintain accurate and up- to- date patient records and document the progress of treatments
  • Monitor and track prescriptions, laboratory results, and other patient information
  • Explain procedures, treatments, and medications to patients and their families
  • Create and maintain positive relationships with patients, their families, and medical professionals
  • Follow clinical guidelines and protocols to ensure patient safety and satisfaction

Experience 0 Years

Level Junior

Education Bachelor’s

Clinical Specialist Resume with 2 Years of Experience

Highly organized and detail- oriented Clinical Specialist with more than 2 years of experience in the industry. Possessing extensive knowledge and experience in assessing patient health, developing and executing treatment plans, performing laboratory and diagnostic tests, and collecting and analyzing data. Skilled in providing patient education, monitoring medical equipment, and phone triage. Known for providing patient- centered care and delivering high- quality results.

  • Laboratory and diagnostic testing
  • Patient assessment and education
  • Patient charting and documentation
  • Clinical research
  • Medication administration
  • Medical device monitoring
  • Phone triage
  • Treatment plan development

Responsibilities :

  • Assessed patient health and performed laboratory and diagnostic tests
  • Collected and recorded data, such as patient histories, vital signs and test results
  • Developed and implemented treatment plans, administered medications, and monitored medical equipment
  • Educated patients on their diagnosis, treatments and medications
  • Maintained patient charts and documentation, while adhering to HIPAA regulations
  • Carried out clinical research and data analysis
  • Conducted phone triage and provided health advice to patients and family members
  • Collaborated with healthcare professionals to determine optimal care for patients
  • Developed patient education materials and provided instruction on medication use and disease management

Experience 2+ Years

Clinical Specialist Resume with 5 Years of Experience

Highly qualified and experienced Clinical Specialist with 5+ years of experience in providing expert advice on health care matters. Proven ability to troubleshoot and resolve complex medical cases with a focus on patient safety. Skilled in providing post- treatment follow- up and patient education. Strong knowledge of medical and nursing procedures.

  • Excellent interpersonal and communication abilities
  • Strong problem- solving skills
  • Proficiency in medical and nursing procedures
  • Highly organized and detail- oriented
  • Compassionate and patient- focused
  • Ability to build strong relationships with physicians and other healthcare professionals
  • Providing expert advice on health care matters to patients and healthcare professionals
  • Assessing and providing follow- up care to patients in accordance with physician guidelines
  • Monitoring patient progress and providing patient education
  • Assisting with research and data collection related to patient outcomes
  • Coordinating with physicians, nurses and other healthcare professionals to ensure the best treatment and care
  • Identifying areas of improvement in the healthcare system and providing recommendations
  • Assisting physicians in developing clinical protocols and policies
  • Documenting patient care activities in medical records and databases

Experience 5+ Years

Level Senior

Clinical Specialist Resume with 7 Years of Experience

Clinical specialist with 7 years of experience in the medical field. Expertise in patient care, patient education, and clinical problem solving. Skilled in building relationships with patients and colleagues, as well as leading teams and project management. Proven success in developing strategies that have resulted in improved patient outcomes.

  • Patient Care
  • Patient Education
  • Clinical Problem Solving
  • Relationship Building
  • Team and Project Leadership
  • Strategy Development
  • Evaluate patient health and wellbeing and provide medical treatments and preventive care.
  • Educate patients on medical treatments, nutrition, and lifestyle modifications.
  • Diagnose and treat illnesses and injuries to ensure optimal patient outcomes.
  • Collaborate with colleagues to develop strategies and plans for patient care.
  • Manage projects and teams to ensure delivery of quality healthcare services.
  • Participate in research projects to identify new treatments and initiatives.
  • Develop and implement clinical protocols and procedures.
  • Monitor patient progress and adjust treatments accordingly.
  • Train and mentor new staff and students.
  • Participate in professional development activities to stay up to date on advances in the field.

Experience 7+ Years

Clinical Specialist Resume with 10 Years of Experience

Clinical specialist with over 10 years of experience in the medical field. Skilled in developing and implementing clinical processes, organizing and leading activities to improve patient outcomes, and maintaining up to date and accurate clinical records. Proficient in auditing and analyzing clinical data, creating reports, and providing clinical resources and support. Driven to ensure safe and effective patient care while working collaboratively with healthcare teams.

  • Clinical Process Development
  • Quality Assurance/Improvement
  • Data Analysis/Reporting
  • Problem Solving
  • Regulatory Compliance
  • Team Leadership
  • Develop and implement clinical processes which meet regulatory requirements and comply with departmental standards.
  • Monitor and evaluate clinical processes and activities for effectiveness and quality assurance.
  • Conduct audits of clinical data and records to identify trends or areas of improvement.
  • Create and deliver reports on clinical and quality data to executive teams.
  • Lead staff meetings, training sessions, and other clinical activities to promote team collaboration and patient safety.
  • Provide education to patients and families on clinical services, processes, and protocols.
  • Troubleshoot issues in clinical processes and procedures to ensure accurate and timely patient care.
  • Ensure regulatory compliance by monitoring changes in regulations and policies.

Experience 10+ Years

Level Senior Manager

Education Master’s

Clinical Specialist Resume with 15 Years of Experience

Clinical Specialist with 15 years of experience in healthcare settings, including acute care, long- term care, and home- health environments. Proven ability to evaluate and assess patient needs, develop and implement treatment plans, provide instruction to patients and staff, and successfully collaborate with colleagues to achieve patient care objectives. Adept at utilizing evidence- based practice and current clinical guidelines to ensure best practice and optimal patient outcomes.

  • Patient Care and Assessment
  • Treatment Planning and Implementation
  • Patient/Staff Instruction
  • Evidence- Based Practice
  • Clinical Guidelines
  • Interdisciplinary Collaboration
  • Documentation and Reporting
  • Medical Terminology
  • Computer Proficiency
  • Evaluate patient needs and provide support and direction to meet those needs.
  • Develop and implement patient care plans, utilizing current clinical guidelines and evidence- based practice.
  • Monitor patient progress and recommend treatment approaches accordingly.
  • Provide instruction and education to patients and staff on disease management and clinical protocols.
  • Collaborate with interdisciplinary teams to coordinate patient care and ensure optimal outcomes.
  • Maintain accurate and comprehensive medical records and reports.
  • Participate in patient care conferences, interdisciplinary meetings, and case management activities.
  • Utilize medical terminology and computer proficiency to create and modify clinical documents.

Experience 15+ Years

Level Director

In addition to this, be sure to check out our resume templates , resume formats ,  cover letter examples ,  job description , and  career advice  pages for more helpful tips and advice.

What should be included in a Clinical Specialist resume?

A clinical specialist is an expert in the medical field who assists in improving the quality of patient care, often through developing and implementing new programs and techniques. They may also help to develop new research initiatives. To be successful in this field, it’s essential to have an impressive resume that accurately showcases your skills and experience. Here is what should be included in a clinical specialist resume:

  • Professional Summary: A short but powerful explanation of your experience, qualifications and key skills.
  • Education: Include any relevant degrees, certifications, and licenses.
  • Work Experience: A comprehensive list of your professional experience, highlighting any special projects, achievements, or awards.
  • Special Skills: Any special skills or knowledge you possess, such as understanding of medical terminology, coding, or other specialized areas.
  • Professional Certifications: Include any additional certifications, such as CPR or first aid, you may have obtained.
  • Professional Affiliations: List any professional organizations or associations you are a member of.
  • Awards and Recognition: Include any awards or recognition you’ve received in your professional career.
  • References: Include a list of professional references who can speak to your experience and qualifications.

What is a good summary for a Clinical Specialist resume?

A Clinical Specialist resume should have a clear and concise summary that outlines the candidate’s experience, qualifications, and accomplishments in the field of clinical practice. It should begin by highlighting the candidate’s core competencies and medical specialty, such as in-depth knowledge of clinical procedures, laboratory and diagnostic services, and patient care protocols. It should also list any certifications or specialized training the candidate has received. The summary should also emphasize the candidate’s ability to effectively communicate with patients, staff, and other health care professionals, and any experience in teaching, research, or administration. Finally, the summary should mention any awards or accolades the candidate has received for their work in the field of clinical practice.

What is a good objective for a Clinical Specialist resume?

A Clinical Specialist resume should be tailored to the specific job for which you are applying. Your objective should clearly outline your qualifications and experience that match the job requirements and provide insight into the value you can bring to the role. Here are some best practices to consider when writing an objective for a Clinical Specialist resume:

  • Highlight your relevant experience and education, such as any clinical certifications or advanced degrees that can demonstrate your expertise in the field
  • Focus on the specialized skillset you have for the position, such as diagnostic and therapeutic skills, as well as any other unique qualifications you have that may set you apart from other applicants
  • Emphasize your ability to work with multidisciplinary teams and collaborate on complex clinical cases
  • Showcase your commitment to patient care and any successes you have had in that regard
  • Mention any awards or achievements you have earned and any other professional recognition you have received
  • Demonstrate your familiarity with the latest medical technologies and your ability to stay up to date with industry trends

By following these tips, you can create an effective objective statement that will grab the attention of potential employers and help you stand out from the competition.

How do you list Clinical Specialist skills on a resume?

Clinical Specialist skills are essential for both medical and healthcare fields. These skills should be included on a resume in order to show a potential employer that you have the necessary skills to excel in a clinical specialist role. Here are some examples of clinical specialist skills that can be listed on a resume:

  • Knowledge of medical terminology: Being able to understand medical terminology is an essential skill for any clinical specialist. Demonstrate your knowledge of medical terminology by including it in your resume and providing examples of any medical terminology courses you may have taken.
  • Patient care: As a clinical specialist, you will be responsible for providing direct patient care. On your resume, explain how you have provided care to patients in previous roles and any specific training you have received in the area of patient care.
  • Problem-solving: Clinical specialists need to be able to identify, diagnose and resolve complex medical problems. Describe your problem-solving skills on your resume, and provide examples of previous problem-solving situations.
  • Communication skills: Clinical specialists must be able to communicate effectively with patients, family members, other healthcare professionals and staff. Explain the communication skills you possess and any training you have received in this area.
  • Leadership: Clinical specialists often work in a leadership role, so it is important to include any leadership experience you have. Explain any experience you have leading teams and managing projects.

By including these skills on your resume, you can show potential employers that you have the necessary skills to excel in a clinical specialist role.

What skills should I put on my resume for Clinical Specialist?

When applying for a position as a Clinical Specialist, it is important to showcase your related skills and qualifications on your resume to make a strong impression on the hiring manager. Here are some skills that you should consider including on your resume for this role:

  • Clinical Experience: As a Clinical Specialist, employers will expect you to have extensive experience in the clinical field. Make sure to highlight any clinical experience you have, such as any courses you have taken, any internships you have participated in, or any relevant volunteer work you have done.
  • Technical Knowledge: This position requires you to have a strong understanding of medical technology and healthcare applications. Make sure to list any certifications you have related to technology, such as IT certifications or EMR certifications.
  • Organizational Skills: Clinical Specialists must have strong organizational and multitasking skills to juggle multiple responsibilities in a fast-paced work environment. Showcase any relevant experience you have managing multiple tasks or projects at once.
  • Communication Skills: As a Clinical Specialist, you will need to be able to effectively communicate with a wide range of people, from patients and their families to medical staff and other healthcare professionals. Make sure to emphasize any experience you have communicating with others, such as in customer service or public speaking roles.
  • Problem-Solving Skills: As a Clinical Specialist, employers will expect you to be able to identify problems and develop solutions quickly and efficiently. Include any experience you have working with data, developing strategies, or troubleshooting issues.

By emphasizing these skills and qualifications, you can make sure that you make a strong impression on the hiring manager and get the job you want. Good luck!

Key takeaways for an Clinical Specialist resume

If you are seeking a job as a Clinical Specialist, crafting a well-written resume is essential for making the best impression with potential employers. There are several key takeaways to keep in mind when composing your Clinical Specialist resume.

First, highlight any relevant certifications or licenses you hold in the medical field. Certifications demonstrate your commitment to staying current in the field and can make you stand out from other applicants.

Next, be sure to include any relevant work experience, such as your current or past clinical positions. Include details such as the type of organization you worked for, your job title, and the duties you performed.

It is also important to include any specialized skills or expertise you possess. For example, if you have experience using a specific type of medical equipment, be sure to mention that.

Also, make sure to include a list of any specialized training or courses you completed related to your field. This can include workshops, seminars, or webinars.

Finally, don’t forget to list any awards or recognition you have received in the medical field. This could include any awards or acknowledgements from professional organizations or colleagues.

By following these key takeaways, you can create a resume that effectively showcases your qualifications to potential employers and can help you stand out from other applicants.

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Clinical Resume Samples

The guide to resume tailoring.

Guide the recruiter to the conclusion that you are the best candidate for the clinical job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.

Craft your perfect resume by picking job responsibilities written by professional recruiters

Pick from the thousands of curated job responsibilities used by the leading companies, tailor your resume & cover letter with wording that best fits for each job you apply.

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  • Perform other duties as assigned by management
  • Assist with management of study-level IP shipment to sites as necessary
  • Assist in implementing process improvement solutions/plans
  • Manage study databases and clinical trial management systems
  • Performs job duties with minimal supervision
  • Provide general administrative and coordination support to the clinical operations department and the development and continuous improvement of departmental procedures
  • Performing data entry into research databases
  • Coordinate and perform a variety of duties involved in the collection of data in support of clinical trials research studies, through clinical assessments, interviews and observation to include interpretation and documentation of data
  • Follow established guidelines in the collection of clinical data and/or administration of clinical trials; assist in the determination guidelines for new protocols
  • Confer with site coordinators and physicians to explain protocol and to elicit compliance with regulations; ensure adherence to FDA and protocol guidelines
  • Prepare a variety of reports, documents and correspondence for regulatory agencies, participating clinical trials sites and internal purposes to assist in the ongoing monitoring and evaluation of the clinical trial's progress
  • Assist principal investigators and/or other members of the research team in the development of plans and protocols for clinical research studies
  • Review work of lower level personnel within designated areas and assist in training new personnel
  • Perform other related duties incidental to the work described herein
  • Assist in writing and editing SOPs to keep current with industry changes on TMF management, quality and archival
  • Works with physicians and medical staff to improve clinical documentation for more accurate code assignments and a more accurate case mix
  • Establishes and maintains a system to track and analyze outcomes of documentation improvement program
  • Performs ongoing medical record review using documentation improvement guidelines to evaluate overall quality and completeness of clinical documentation
  • Assist with User Acceptance Testing during product development and release
  • Assists with Quality Management to ensure compliance of pathways and quality initiatives
  • Assist senior document specialists for performing internal audits
  • Comprehensive health care, dental, vision, life and disability plans
  • Proficiency in hospital pharmacy practice, patient-centered care, advanced pharmacy practice, medication therapy management, and evidence-based medicine
  • Previous management or project management experience with demonstrated leadership ability
  • Excellent communication; interpersonal skills and influencing skills
  • Ability to determine the people, funding, materials and support to meet project goals and timelines
  • Proficiency with hospital computer systems, pharmacy technology, and pharmacy automation
  • Able to work in ambiguous, fast-paced environment
  • Able to work independently
  • Excellent time management skills (timelines, schedules, task prioritization)
  • Willing and able to travel up to 30% of time

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Clinical Resume Sample

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  • 5+ years of experience as a Clinical Pharmacist, 3 of which must have been in a hospital
  • Critical care, drug information and clinical experience

Clinical Unit Coordinator Resume Examples & Samples

  • 5+ years community health or ambulatory clinic experience
  • Strong clinic background working with adults 18+
  • Spanish-speaking

Clinical Assessment Temp Trainers Resume Examples & Samples

  • Preferred Licensed Psychologist
  • Minimum 5 years of experience with administration and interpretation of Clinical Assessments
  • Proficient in MS Office Suite
  • Proficiency with applications that run across the Worldwide Web
  • Overnight travel required
  • Effective Time Management
  • Professional and polished demeanor
  • Personal laptop ownership and use required
  • Please note: This is a temporary opportunity, billed through a third party
  • This is not an active opening, so you will not be immediately contacted. Thank you for your interest with HMH

Temporary Clinical Examiners Resume Examples & Samples

  • Administer and score a battery of individually administered tests
  • Ensure all tests and forms are completed accurately and submitted in a timely manner
  • Keep accurate records of assigned cases and examinees
  • Some travel may be required. Job Requirements
  • Minimum of Master's degree in Special Education, Psychology, Educational Psychology or Speech Language Therapy
  • Familiarity with a variety of individually administered clinical assessments and observational instruments
  • Access to a wide range of potential examinees, based on various demographic characteristics
  • Proficient in MS Office Suite (Word, Excel)
  • Proficiency with email and internet
  • Personal computer ownership and use required
  • Ability to work evening/weekend hours as needed

Head of Clinical Data Systems Resume Examples & Samples

  • BS/BA in a scientific or programming discipline
  • Minimum 12 years experience as a Clinical Data Manager in a CRO or pharmaceutical/biologics/biotechnology company with increasing scope of responsibility demonstrated
  • Experience in a pharmaceutical/biologics/biotechnology company must include management of outsourced CDM and clinical programming activities
  • Expert knowledge of eClinical processes, efficient design/build of an EDC data management system (Rave, Oracle RDC) and other Clinical Trial data/Data Management Systems
  • Intimate knowledge of regulations and industry adopted data standards, such as CDISC-SDTM and CDASH and other associated clinical data submission deliverables
  • Demonstrated advanced expertise with clinical programming in SAS (at least 5 years)

Director of Campaign Marketing, Clinical Resume Examples & Samples

  • Lead generation and revenue creation for field sales team and direct selling
  • Channel Support in the form of selling and marketing tools and training
  • North American campaign planning for Clinical solutions including school. and healthcare/non-school markets including Talent Assessment
  • Create, implement, and monitor marketing plan, campaign plan & budget for responsible area for new product launches and portfolio
  • Drive Pearson brand in responsible market segment
  • Events strategy for responsible area in alignment with North American Geography strategy
  • Competitive analysis & distinction, win loss analysis for responsible area
  • Customer segmentation
  • Support for Customer relationship management
  • Creation and successful implementation of marketing plan for responsible area
  • Identify customer needs and market trends and recommend pricing strategies

National Account Executive for Clinical Assessments Resume Examples & Samples

  • Designs strategies that address customer needs and issues while meeting assigned quota; targets and prioritizes accounts and activities; analyzes competitors' activities and adjusts appropriately; utilizes area, national and Per Diem resources effectively
  • Strategically plans sales calls by outlined objectives and action steps
  • Reads the market, recognizes trends, and communicates that information to the Area Management; Demonstrates knowledge of account history, the processes and procedures specific to each district, and the key issues for each account
  • Responds to customers requests and problems with appropriate timeliness and concern; Develops professional credibility and trust with the customer
  • Provides timely and complete information needed for consultants and outside resources to perform effectively in the territory; Uses voicemail and email appropriately; Updates Salesforce.com regularly
  • Knowledge of each clinical assessment to converse comfortably with customers and understand their needs; effectively communicates the major features, advantages, and benefits of each product; Displays a thorough knowledge of state and national clinical assessment and early childhood trends and movements in order to be at the right place at the right time

Senior Non-clinical Study Coordinator Assoc Resume Examples & Samples

  • 50% Administrative oversight and management of operational aspects of outsourced studies at Shire approved CROs from study initiation (study time lines, budgets, protocols, test article availability & shipment) to report finalization. Coordinate internal (Shire NCD) and external (CRO) protocol review. Monitor study activity and data to ensure time lines are adhered to. Primary Shire point of contact with CRO
  • 20% Administrative oversight of program finances (PO requisitions, invoices, vendor management), track study timelines and budget. Work with legal affairs and Global Procurement to ensure that requisite vendor contracts (MSAs, SOWs, CDAs, etc.) are created and maintained
  • 10% Ensure alignment of Shire Internal Compliance/Quality Assurance Units and corresponding functions of CROs during all phases of regulated nonclinical work
  • 10% Review study data on an ongoing basis and provide toxicologists with data summaries. Coordinate internal (Shire NCD) and external (CRO) report review. QC nonclinical sections of regulatory submissions
  • 10% Ensure best practices are in place for operational efficiency within the department and externally with CROs

Clinical Trial Transparency Manager Resume Examples & Samples

  • 50% Internal and External Transparency and Data Sharing Project Support
  • In collaboration with other members of the CTT team, the manager contributes to the public disclosure of clinical trial protocol information and results for clinical studies in line with regulatory requirements and Shire public disclosure policy and strategy
  • Transparency manager is responsible for preparing or managing the preparation of the content to be posted on external websites
  • The manager needs to interact closely with the clinical/statistical study team as well as with other key functions such as regulatory, compliance, corporate communications, legal, etc
  • Provide operational support to ensure the alignment of posted information across all external websites
  • Redacts and/or coordinates the redaction of patient sensitive or commercially confidential information
  • Assists with development and maintenance of processes and systems to optimize efficiency, maximize content reuse and ensure quality. Evaluates trends and identifies areas for improvement
  • Participates in industry working groups (e.g. DIA Disclosure Community) to ensure a firm understanding of the activities affecting transparency. Monitors the clinical trial transparency landscape, including regulatory requirements and industry trends
  • Supports CTT team for coordinating updates of on-going studies following protocol amendments or changes in monitoring information
  • Oversee/manage the review process to ensure timely and accurate postings, and to ensure that information is posted on appropriate public clinical trial registries and updated as required per regulations and internal SOPs
  • Responsible for managing/overseeing the management of external requests for access to Shire Clinical Trial Data including, but not limited to

Clinical Programs Lead Resume Examples & Samples

  • Bachelor’s degree or nursing qualification is required. Scientific/health care field preferred but not required. Advanced degree preferred
  • Significant clinical research experience (8+ years) with evidence of increasing responsibility within a pharmceutical company or CRO
  • Global clinical trial research experience
  • Experience leading cross functional teams
  • Participation in marketing application review and submission is preferred
  • Experience managing financial budgets is preferred
  • Must be able to design drug development programs as well as create program and/or study level documents
  • Strong knowledge of applicable computer and project management software packages
  • Demonstrated ability to present information to Shire management, CROs and external audiences (as applicable)
  • Ability to oversee and/or manage and communicate effectively with research vendors including negotiating contracts, reviewing request for proposals, analyzing scope of work, responding to inquiries and complaints
  • Strong interpersonal skill set necessary to create and maintain external collaborator relationships (e.g. Key Opinion Leaders)
  • Demonstrated ability to prioritize across program / study demands ensuring overall quality
  • Requires strong attention to detail and the ability to establish priorities schedule and meet deadlines
  • Ability to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands
  • Ability to work independently, take initiative and complete tasks to deadlines
  • Demonstrated ability to motivate & mentor staff
  • Displays a high level of professionalism with internal and external stakeholders
  • Develops project plan(s) to achieve long-term goals based on higher business level drivers and strategies
  • Demonstrated ability to create and manage program and/or study budgets including communication of overspend /underspend risk and mitigation efforts
  • Communicate with key internal and external stakeholders to ensure success and looks for opportunities for collaboration
  • Respectfully challenges current practices, decision or ideas to uphold quality or ethical standards

Clinical Document Specialist Resume Examples & Samples

  • Records management experience
  • Familiarity with various aspects of clinical trials and regulatory submissions. Current awareness of regulatory requirements for clinical trials (ICH/GCP)
  • Sufficient knowledge of regulatory requirements and guidelines (ICH/GCP to support records management
  • Ability to communicate effectively with external vendors, including issue escalation, and responding to enquiries and concerns
  • Must be able to work in a fast paced environment with demonstrated ability to prioritize multiple competing tasks and demands
  • Demonstrated ability to be flexible and to adapt quickly to chang

Director of Clinical Programs Resume Examples & Samples

  • Ensure performance standards are realistically set and attained for internal and external resources
  • Oversee management of sites and vendors to issue resolution if necessary
  • Align with team members from other functional areas regarding plarming, implementation, tracking, analysis and reporting of milestones

Clinical Trial Transparency Team Lead Resume Examples & Samples

  • 40% Leads Internal and External Transparency and Data Sharing Projects and Strategic Transparency Initiatives
  • Leads internal core team and/or subteams in support of strategic transparency initiatives
  • Assesses impact, identifies action required, and communicates needs to applicable functions and senior management
  • Participates in industry working groups (e.g. DIA Disclosure Community SIAC) to ensure a firm understanding of the activities affecting transparency
  • Actively participates in external initiatives to represent the company position in support of transparency activity and development of industry standards
  • Delivers presentations to key functional areas and at all levels of the organization
  • Proposes and leads activities that support evolving strategy for clinical trial transparency
  • 30% Process and System Development
  • Acts as owner of Clinical Trial Transparency processes
  • Lead Committees and cross-functional Working Groups to establish strategy and policy, develop and implement processes, and ensure compliance with global requirements
  • Evaluates trends and identifies areas for improvement. Leads process analysis efforts and identifies opportunities to improve efficiency and effectiveness
  • Represents Clinical Trial Transparency Group on internal and external work streams related to automation systems and other proposed changes that may impact policy and procedures related to clinical trial transparency
  • 20% Operational oversight and overall strategy for Aggregate Spend Reporting
  • Collaborates with Corporate Compliance to develop department-specific data collection processes
  • Oversees data collection and formal reporting activities for Global Clinical Development Operations
  • Oversees monthly submission into Shire’s reporting database
  • Works closely with internal support functions including Finance, Supply Chain, and IT to ensure proper mechanisms are in place globally to capture required information
  • Promotes accurate reporting by ensuring GDCO meets or exceeds industry standards for recording and managing HCP payment requirements
  • Stays abreast of all international, federal and local reporting requirements
  • Advises leadership on changes to requirements as required
  • 10% Resource Management
  • The Lead is responsible for oversight and development of internal and external resources
  • Oversees transparency operations to ensure requirements and timelines are met while maintaining high quality and continuously improving process efficiency
  • Works with the Transparency staff members to ensure alignment across all areas of transparency, including other related functional areas, business units, and global locations
  • Builds capabilities through mentoring/coaching
  • Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the teams and stakeholders in an open, balanced and objective manner
  • Development and maintenance of team budget
  • Sponsors training programs for department staff     
  • Bachelor's degree in scientific or related field is required; advanced degree is preferred
  • Minimum 10 years pharmaceutical / biotechnology or relevant industry experience
  • Experienced in leading global cross-functional teams in a matrix organization
  • Ability to effectively represent the department internally, as well as the company externally
  • Excellent negotiation skills, conflict resolution, decision making skills, communication (oral and written) and presentation skills
  • Ability to interact well with all levels of the organization
  • Coordination and planning of budgets, people and time management
  • Problem solving at a strategic level, working with others to reach a resolution
  • Ability to discuss strategic and sensitive issues
  • Confident and influential approach

Lead Clinical Standards Specialist Resume Examples & Samples

  • 30% - Delivering Excellence: Takes leadership role in coding and standards project implementation
  • Acts as Standards area project manager for selected standards / coding projects
  • Mentors team members via matrix relationships in standards and coding implementation and optimal usage
  • Owns, governs and maintains designated GCDO developed standards models (including but not limited to: SDTM ,CDASH, Terminology, ADaM, TFLs, document templates, questionnaires). Includes periodic assessment of standards content with respect to compliance and industry impacts
  • Lead assessment, implementation, integration and governance of systems and tools to support, manage, govern and report on standards
  • Ensure enforcement and assessment of standards compliance
  • Collaborates closely with data management service providers to ensure appropriate management, training and deployment of Shire’s standards within the service providers infrastructure
  • Represents Shire and Global Clinical Development Operations as a member of industry content development groups (e.g. CDISC)
  • Leads a R&D Standards Area Working Group/Team
  • Supports standards library, knowledgebase/governance portal and other applications. Coordinates with IT where necessary
  • Develops or assists in the development of tools to manage standards
  • Contributes to budget forecasting and resourcing requirements
  • 20% - Accountability and Ownership: Drives accountability at every possible level
  • Collaborates with Standards Team lead to identify and resolve issues impacting goal attainment
  • Develops and delivers training programs to affected internal and external staff
  • Ensures CROs and Shire are deploying standards / coding guidelines and leveraging them across the organization at an enterprise level
  • As designated, ensures a consistent strategy of adverse event and concomitant medication coding across programs and impacted functions
  • Ensures timely communication of new and/or revised standards. Provides timely feedback to user inquiries
  • May manage contract staff
  • 20% - Judgment and Decision Making: evaluates immediate business impact and takes decisive action
  • Maintains currency with changes in the external standards landscape and assists in development of recommendations for actions
  • Reviews standards deployment strategies and activities at the CRO to ensure optimal benefit for Shire
  • Keeps current with industry developments and strategies related to standards
  • As designated assesses and communicates impacts of MedDRA and WHO Drug dictionary updates to Shires Coding guidelines as they are released
  • As designated, coordinates with IT to manage MedDRA and WHO Drug upgrades
  • 15% - Serving Customers: Partnering with customers as a trusted consultant and becoming an integral part of customer’s decision making
  • As designated, coordinates with Pharmacovigilence & Risk Management (PVRM) & Physician groups to manage updates to Shire’s Coding Guidelines
  • Consults within and across Global Clinical Development Operations, and the data management service providers to identify gaps, risks and inefficiencies and works with Standards Team lead on solution development
  • Ensures overlaps and conflicts are resolved and continuity of “end to end” standards is maintained
  • Represents Global Clinical Development Operations in cross-functional standards and coding project teams
  • Collaborates with Global Clinical Development functions to ensure optimal process design leveraging standards infrastructure and scope
  • 15% - Building Authentic Relationships: Building trusting relationships that will enhance current and future needs
  • Coordinates with Standards Team Lead and peers to prioritize and deliver standards related initiatives
  • Guides and supports activities of standards management vendors
  • B.S. degree in Scientific or related field is preferred
  • Minimum 5-7 years in Data Management/Programming/Statistics or other Clinical Research related fields
  • Experience with at least one of the CDISC standards
  • Optionally, exposure to and understanding of MedDRA / WHO Drug coding Dictionaries

Head of Clinical Operational Excellence Resume Examples & Samples

  • Bachelors Degree required, preferably in a scientific field; MBA or other advanced degree preferred
  • Minimum of 12 years clinical research experience in pharmaceutical or biotechnology field
  • Minimum 9 years management experience in clinical research setting
  • Education, experience and documented results in providing clinical operations support

Clinical Auditor Resume Examples & Samples

  • Utilizes encoders and various coding resources
  • Maintains strict patient and physician confidentiality and follows all federal, state and hospital guidelines for release of information
  • Maintains current working knowledge of ICD-9 coding principles, government regulation, protocols
  • Ability to travel 10% or less of the work year for training, team meetings, possible onsite audits opportunities and implementation needs
  • RHIA, RHIT, or CCS credentials
  • Inpatient auditing experience
  • 3+ years coding experience
  • Demonstrated ability to exercise solid judgment and discretion in handling and disseminating information
  • Customer-service focused and exhibit professionalism, flexibility, dependability, desire to learn, commitment to excellence and commitment to profession
  • Excellent writing, editing, interpersonal, planning, teamwork, and communications skills
  • Associate's Degree in relevant field preferred
  • Nurse Coder Background
  • ICD-10 Trainer certification from AHIMA a plus
  • Training with inpatient coding

Clinical Guidance Specialist Resume Examples & Samples

  • Prior Call Center experience
  • Ability to work 9am to 6pm central time zone; Monday through Friday
  • Prior Heatlhcare experience with knowledge of billing or pre-authorization approval process

Clinical Messaging Portfolio Consultant Resume Examples & Samples

  • Develop and implement a robust, dynamic project portfolio management process for the evaluation and prioritization of messaging projects with the ability to influence and drive consensus with both internal and external team members
  • Lead intake and strategic review of new initiatives to challenge and review submissions, and to provide content, preparation and prioritization of the funding requests for projects by ensuring alignment with organizational objectives
  • Support development of consumer clinical messaging strategies with clear understanding of the business problem, view of the system, strategic proposals and plans to specific business partners as aligned
  • Creates and oversee current department processes and recommend new approaches for process improvement and re-engineering to ensure optimal allocation of resources
  • Manage department budget and resource model
  • Supports portfolio assessments by working with business leads and consultants to prioritize new and existing projects based on strategic priorities, compliance requirements, and customer demand
  • Ensures effective performance and status reporting to leadership for all programs and projects within the portfolio
  • Collaborate and partner with key stakeholders from enterprise messaging, consumer marketing, data analytics and consumer experience teams
  • Establish and maintain relationships with individuals at various levels of the organization, such as peers, internal/external stakeholders, business partners, and senior level managers
  • Oversee and maintain departmental process discipline requirements for Internal Quality and Audit
  • Ability to develop and implement criteria for evaluating projects ability to build project portfolio as well as strategic roadmaps
  • Experience managing large-scale projects (3-5 years or more)
  • Experience working with multiple stakeholders to deliver key business goals and objectives
  • Ability to oversee multiple cross-functional projects simultaneously
  • Excellent communication and consultation skills
  • Possess an understanding of business metrics and reporting, communications and processes
  • Ability to manage budgets and review financial data
  • Experience using project management tools
  • Experience in using Microsoft Office and PowerPoint
  • Experience with operations and technology
  • Previous experience in healthcare
  • Experience with Project management/PMP, Process improvement /Six Sigma and Program Management

Clinical Messaging Campaign Management Consultant Resume Examples & Samples

  • Be the subject matter expert on enterprise campaign management for Proactive Care Strategies
  • Consult with business partners both inside and outside of Proactive Care on capabilities within campaign management
  • Partner with other members of Proactive Care, business and IT partners in order to develop the optimal campaign build for the given communication / situation
  • Providing expertise in the optimization, measuring and monitoring of campaigns
  • Capitalizing on Next Best Action, Multi-Variant testing and Test/Adjust opportunities
  • Self-starter and problem solver
  • Proficient with SQL
  • Demonstrated ability to function in a consultative capacity
  • Experience building campaigns in a campaign management system and/or working with CRM solutions (ideally 2+ years)
  • Campaign Management experience with IBM Campaign (Unica)
  • Familiarity with Humana core systems
  • Previous IT development experience
  • Consumer behavior or direct response marketing experience

Clinical Innovations Specialist Resume Examples & Samples

  • Knowledge of CGX and CCP2
  • Excellent both verbal and written communication skills
  • Associate’s or Bachelor’s Degree in Business
  • Experience with CIT and CCRT

Internal Audit Clinical Consulting Leader Resume Examples & Samples

  • Bachelor’s degree in nursing is required. Only candidates with an RN license will be considered
  • 4 to 6 years of process, risk management, consulting or clinical experience
  • Likes to focus on the "big picture" and thrives in a fast paced, multi-project work environment
  • Computer literate (MS Word, Power Point, Excel)
  • Knowledge of Humana’s internal policies and procedures

Clinical Performance Improvement Consultant Resume Examples & Samples

  • Strong analytic skills and the ability to use data to drive improvement activities
  • Previous management and operations experience leading teams focusing on operational improvement and performance management
  • Executive-level communication skills, written and verbal that can be applied to external audiences as well as internal audiences
  • Excellent PC skills (including MS Word, Access, Excel and PowerPoint)
  • Strong database software proficiency
  • Comprehensive knowledge basecrossing all areas within quality and HEDIS programs
  • Strong analysis and problem solving skills
  • Strong relationship building and communication skills

Clinical Technical Lead Resume Examples & Samples

  • Work closely with the Architecture team in understanding the Architecture and the future direction for the application
  • Work closely with the Development team and provide design specifications that align with the Architecture to deliver on the business requirements
  • Build a standards-driven, scalable, secure and dynamic portal for managing claims authorizations
  • Occasionally develop enhancements, resolve issues, coordinate testing of statement releases and oversee regular production efforts
  • Partner with other business areas within Humana to understand application requirements and develop programming specifications for development staff
  • Bachelor’s Degree in Computer Science, Information Systems or equivalent experience
  • Expertise in object-oriented programming concepts, design patterns and service-oriented architecture
  • Good understanding of web development architecture and design
  • Strong C#.net programming experience
  • Experience in the areas of software development and support
  • Development experience using Visual Studio, ASP, XML, HTML, WCF and SQL
  • Comprehensive understanding of SDLC, waterfall and/or agile methodologies
  • Strong experience in web development with C#/.net, MVC
  • Knowledge of Microsoft Biztalk 2009 or higher
  • Experience leading a development team (4+ developers)
  • Health Care Industry experience
  • UML documentation knowledge

Clinical Audit Consultant Resume Examples & Samples

  • Process improvement and development experience
  • Must be able to present to upper leadership
  • Experience in creating work-flows
  • Comprehensive knowledge of Microsoft Word, Excel, Visio, Powerpoint and Access
  • PMI certification

Client Strategist Clinical Rules Portfolio Resume Examples & Samples

  • Manage multiple, complex initiatives, developing successful partnerships with a strong customer focus
  • Provide clinical subject matter expertise in consultation with clients and leverage voice of the customer to help shape the development of population health tools and services
  • Engage clients to demonstrate the value of our population health, clinical analytics, interoperability tools and services and advocate for adoption with clinical workflows
  • Leverage a deep understanding of market conditions and client needs to plan the clinical rules roadmap and ensure existing rule assets are renewed to stay current with clinical specifications
  • Partner with clients to ensure that the value proposition of deployed solutions is being realized
  • Experience in a clinical setting (hospital, primary care, specialty, etc.)
  • Working knowledge of clinical data types and data sources (Claims, Rx, Labs, CCD, etc.) and data standards (CDISC)
  • Knowledge of clinical quality measures (CQM) and industry standard measure sets such as HEDIS, Stars, ACO, or MU
  • Understanding of industry regulation and familiarity with accrediting agencies and government agencies (NCQA, NQF, CMS, etc.)
  • Minimum of a Bachelor's Degree (B.S or B.A) in nursing, biological sciences or related discipline
  • Understanding of MSO and ACO risk relationships, shared savings, and delivery networks
  • Experience with Medicare, Medicare Advantage, and Medicaid regulatory and quality requirements
  • Experience with electronic medical records (EMR), health information exchanges (HIE), health information technology (HIT)
  • Experience working within a dynamic startup or software product company in health information technology or related industry
  • Advanced degree (M.S., Nurse Practitioner, MPH or Ph.D.) or licensor/certification (CCM, APRN) is a plus

Sun Quest Clinical Application Analyst Resume Examples & Samples

  • Participate as a team member in supporting the various aspects of healthcare Clinical workflow processes such as OE, Lab, Radiology, OR, ER and query report writing as well as ancillary departmental systems
  • Provide laboratory application technical support for multiple sites
  • Responsible for the execution of projects and enhancements within clinical environment to support the business needs of the departments
  • Provide level 2 support in response to user problems and questions regarding functionality, operations, input/output, reporting and general operating procedures
  • Perform modifications and/or enhancements to systems including changes to profiles, master files, reports, screens, systems design, conversion requirements and documentation requirements
  • Provide/recommend innovative ideas, processes and/or procedures for enhancements, additions, modifications to improve the existing systems
  • Perform specific work relevant to the service delivery area that meets/exceeds key performance criteria, SLAs and customer expectations
  • Prepare status reports for assigned projects
  • Perform troubleshooting and analysis
  • Analyze business and regulatory requirements and applies these requirements to systems programming
  • Create/modify queries and reports
  • Work on a variable, rotating on-call duty
  • Undergraduate degree and 0-2 years of relevance experience
  • 2+ years of clinical application experience in the healthcare environment
  • Strong analytical and communication skills
  • Knowledge of clinical and ancillary departmental systems, query report writing and integration and system implementation skills
  • Experience with SunQuest Laboratory, McKesson HRM Radiology, Clinicomp Labor and Delivery, Radiology, Medical Records and other ancillary systems

Clinical Systems & Technologies Lead Resume Examples & Samples

  • 40% - Delivering Excellence: Takes Leadership Roles in Projects and Project Implementations
  • 25% - Leading and Managing
  • 8+ years experience in Data Management, Clinical IT, or other Clinical Research related fields

Clinical Audit Analyst Resume Examples & Samples

  • Proficient knowledge of Microsoft Word, Excel
  • Microsoft Access (having the ability to create a query and launch theoretical claims in the system)
  • Process documentation and workflows
  • Strong analytic skills
  • Strong written and verbal communication Skills
  • Self-Starter—high level of initiative
  • Works well with ambiguity
  • MTV and/or CAS Platform experience
  • Proficient in Microsoft Visio, PowerPoint

Clinical Innovations Specialist Peoria Resume Examples & Samples

  • Professional appearance and attitude
  • Proficiency in Microsoft Office Word and Excel
  • Previous healthcare or health insurance experience preferred

Metrician Clinical Intelligence & Analytics Resume Examples & Samples

  • Bachelor’s Degree in Math, Statistics, Economics or a related field
  • Prior statistical experience
  • Ability to communicate statistical and technical concepts in a manner that is easy to comprehend
  • Experience using SQL and/or SAS
  • Graduate Degree in Applied Mathematics or Statistics
  • Experience with large data sets and/or the analysis of patient-level healthcare data
  • Experience with propensity score matching techniques and ROI analysis
  • SAS programming certification

Frontline Leader, Non-clinical Specialists Resume Examples & Samples

  • Administrative experience in call center environment
  • Prior experience in supervisor or mentor/SME capacity
  • Valid drivers license and/or dependable transportation necessary
  • BSN or Bachelors degree in a related field

Clinical Reimbursement Manager Resume Examples & Samples

  • Bachelor of Science in Nursing required
  • MDS and PRI experience required
  • RACC certification preferred
  • Long term care experience required, preferably within a CHHA
  • Knowledge of Medicaid and Medicare

Clinical Sample Coordinator Resume Examples & Samples

  • Certification as a Medical Laboratory Technologist, MLT (ASCP) or CLS (ASCP) preferred
  • Experience working in a biomedical or clinical research organization
  • Experience in procuring and managing bio-specimens and automated specimen processing
  • Experience in core facility operations and laboratory information management systems
  • Exposure to database platforms and programs preferred
  • Bachelors degree in a health related field and/or business or work equivalent experience
  • Proven track record in provider education, performance improvement/Quality Improvement work in health- with associated professional degree
  • Experience in completing efficient health-related research, with associated analysis and conclusions
  • Previous operations experience coordinating teams focusing on operational improvement and performance management
  • Comprehensive knowledge base crossing all areas within quality and HEDIS programs
  • Certified Coder/Coding Educator is highly desirable

SVP & GM, Clinical Reference & Workflow Resume Examples & Samples

  • Manage a team of 50+ FTEs and be responsible for more than $150m of revenue
  • Create the product/portfolio vision and manage the entire product life cycle
  • Own, champion and manage the development and execution of product/portfolio business plans that solve customer needs
  • Seek new market opportunities within the company's distinctive competence
  • Develop and manage the portfolio budget
  • Specify market requirements for current and future products by conducting market research supported by on-going visits to customers and non-customers
  • Work and ensure tight alignment with key stakeholders including Sales, Business Development, and Marketing to develop go to market strategies, sales and usage targets, pricing, packaging, etc
  • Analyze and identify potential partner relationships and acquisition candidates for the product and channel
  • Continuously monitor market and competitor trends and develop plans to proactively address
  • Measure, monitor, and report the success of the solution based on defined goals
  • Develop and refine action plans to ensure success
  • Represent Elsevier and evangelize, both internally and externally, the product offering
  • Drive a solution set across development teams (primarily Development/Engineering, and Product Marketing and Customer Marketing) through market requirements, product contract, and positioning
  • Interface with internal customers (IT, Production, Operations Groups) to ensure the needs of the business are understood and incorporated into the vision
  • Minimum of 10+ years in healthcare market
  • Experience in managing cross-functional teams a plus
  • Experience in product development and workflow solutions
  • University degree and MBA required
  • Strong strategic perspective and driving results
  • Experience in marketing, business development and developing and launching new products is critical
  • Entrepreneurial skills and good in starting up new initiatives
  • Excellent oral and written communications skills in both English & Spanish
  • Proficiency in Microsoft Office applications, including Word, Excel and Power Point
  • Previous inbound call center experience
  • Knowledge in Medical Terminology (ICD-9, CPT, HCPC's)

Clinical Interoperability Process Consultant Resume Examples & Samples

  • Identify and resolve barriers to performance from determining root cause analysis, creating process mapping and resolution – implementation
  • Oversee the improvement process
  • Ensure standardization of processes within and between all service centers
  • Promote the implementation of best practices
  • Prior demonstrated experience with process improvement or process design and implementation roles
  • Comprehensive knowledge of all Microsoft Office applications, including Word, Project and Visio
  • EMR subject matter expertise
  • Provider facing experience
  • Must be able to travel a minimum of 25% and maximum of 100%
  • Epic subject matter expertise and willingness to learn other EMR’s as needed
  • Clinical Degree

Clinical Guidance Consultant Resume Examples & Samples

  • Associates or Bachelor’s in Nursing (RN or LPN)
  • Active LPN/RN in state of residence and can work without restrictions
  • Certified Professional Coder (CPC)

Clinical Metrics Analyst Resume Examples & Samples

  • Design, development, and deliver of operational reports, dashboards, and adhoc requests
  • Develop and establish strong and effective working relationships with clinical program leadership and other departments
  • Derive observations and insights from metrics to support and improve clinical operations
  • Bachelor’s Degree in Business, Information Technology, Mathematics, or equivalent work experience
  • 2 to 3 years or more of reporting experience
  • Must have the following experience with Microsoft Access: building tables and querying tables
  • Must have the following experience in Microsoft Excel: build pivot tables, GETPIVOTDATA function, math functions, VLOOKUP, and building graphs
  • Ability to interview business owners to define the need/problem/desire of a request and understand how best to fill the request to drive value
  • SQL/SAS knowledge a plus
  • Strong problem solving and troubleshooting skills, especially around data acquisition, transforming data into information, and delivering information effectively
  • Assist team consultants and business leaders in understanding the “story” contained within or behind the data/report
  • Ability to see trends and provide advice regarding root cause(s) of any trend (positive and negative)
  • High collaboration and consensus building skills (assuring that reports align with stated operational goals and/or strategy initiatives)

Clinical Innovations Analyst Resume Examples & Samples

  • Builds Trust: Consistently models and inspires high levels of integrity, lives up to commitments, and takes responsibility for the impact of one's actions
  • Collaborates: Engages others by gathering multiple views and being open to diverse perspectives, focusing on a shared purpose that puts Humana's overall success first
  • Customer Focus: Connects meaningfully with internal customers to build emotional engagement and internal customer advocacy. Simplifies complexity and integrates internal efforts to deliver an optimal customer experience
  • Work with business users to define and document requirements for analytics projects
  • Develop analyses, on-demand reports, and scheduled reports using database queries and business intelligence tools
  • Facilitate communication between business users and IT partners
  • Prior experience working in healthcare system analytics and/or data warehousing environment
  • Advanced SQL knowledge
  • Advanced degree in Business, Engineering, Math, Statistics, Health Administration, Public Health, Finance or other health related field preferred
  • Prior experience using Base SAS or SAS EG
  • Certified Medical Coder with at least one of the following credentials: CPC, CCS, RHIA, RHIT
  • 3+ years prior coding experience and outpatient auditing experience
  • Proven proficiency across a wide range of services, which include evaluation and management, anesthesia, surgical services, radiology, pathology and medicine
  • Strong written and verbal communication skills; strong analytical, organizational and time management skills

Market Clinical Strategies Analytics Manager Resume Examples & Samples

  • Identify gaps in current reporting abilities or packages and pursue enhancement opportunities for new or established reporting packages
  • Utilize Clinical Datamart knowledge to identify and communicate system related enhancements to key stakeholders within Humana’s managed care departments
  • Bachelor’s degree in Business or Information Technology or related field
  • Minimum two years of experience with SQL reporting (SQL Server Enterprise Manager, SQL Server Management Studio, etc)
  • Minimum two years of experience with health care data reporting
  • Proven experience analyzing very large data sets
  • Proven experience developing metrics to track large programs
  • Proven experience presenting outcomes and data to executive team
  • Strong organizational and multi-tasking skills required
  • Previous experience with Humana clinical systems (i.e. CCA, CCP2, CGX, Atlas/QSM)
  • Performs Verint validation reviews
  • Utilizes audit tool
  • Conducts reviews to ensure compliance with guidelines and provides reports to manager/leader as directed
  • Maintains strict patient health information confidentiality and follows all federal and state guidelines
  • Maintains current working knowledge, principles, government regulation, protocols
  • An RN with an active nursing license
  • At least 3-5 years nursing experience
  • Computer proficient with MS Office products including; Excel, Word and Outlook
  • Prior auditing experience
  • Previous experience working in a skilled nursing facility (SNF)
  • Prior experience in SNF review

Clinical Need Intern Resume Examples & Samples

  • Understand current status of research and development in the laboratory
  • Work closely with the team of engineers and researchers to assess and prioritize clinical unmet needs
  • Review medical and scientific literature to draft a clinical need statement
  • Review market research and competitive landscape to evaluate business opportunities and define value proposition for innovative medical technology
  • Educate colleagues about human anatomy and current clinical practice for relevant technology areas
  • Education: Current medical student, preferably in the final years of the joint MD/MBA program

Proactive Clinical Strategies Director Resume Examples & Samples

  • Bachelor’s Degree in Business, Marketing and Communications or a related field
  • Prior work experience in the health solutions industry with demonstrated success directing and leading teams
  • Experience creating strategy and executing the strategy to achieve the business goal
  • Experience working with internal and external partners
  • Proficiency in analyzing and interpreting trends
  • 7 years or more of professional experience
  • Comprehensive knowledge of all Microsoft Office applications, including Word, Excel and PowerPoint
  • Demonstrated success in large scale collaborative efforts
  • Customer Service or Member Experience background
  • Marketing or member communications background
  • Experience working with Voice Activated Technology vendors and/or call centers

Clinical Specialst San Juan Resume Examples & Samples

  • Capacity to manage multiple tasks
  • Excellent oral and written communications skills in Spanish
  • Ability to work under tight schedule and under pressure
  • Excellent oral and written communications skills in English

Clinical Document Manager Resume Examples & Samples

  • 6+ years in the pharmaceutical, biotechnology or medical device industry with at least 3 years of experience in Clinical Trial Master File management
  • Demonstrates thorough knowledge and understanding of regulatory authorities, GCPs, ICH guidelines and regulatory requirements for TMFs
  • Demonstrates a high level of knowledge of clinical operations’ methodologies and organizational capabilities
  • Strong record of delivering process improvement projects
  • Strong verbal, written, presentation and interpersonal skills
  • Additional experience in GCP Quality Assurance
  • Knowledge of eTMF systems

HPS Clinical Formulary Management Analyst Resume Examples & Samples

  • Builds new formularies and drug lists in Humana’s formulary management system
  • Performs weekly maintenance and updates of formularies and drug lists
  • Completes formulary submissions to Medicare and Commercial Plans
  • Becomes an expert in Humana’s formulary management system and prescription drug data
  • Performs extensive formulary analysis and reporting
  • Partners with pharmacists, healthcare professionals and operations staff in a team environment
  • Develops appropriate analysis and metrics to deliver process improvements and business results
  • Creates documented processes and training materials
  • Excellent data analysis and experience working with MS Access and Excel
  • Knowledge/experience working with SQL (via MS SQL Server, Oracle, PL/SQL or other)
  • Three years’ experience in a health services or technical field
  • Pharmacy or pharmaceutical related background
  • Familiarity with MS Word and Visio

Clinical Audit Supervisor Resume Examples & Samples

  • Bachelor’s Degree in nursing
  • Five years varied clinical experience
  • Two years of management experience
  • One year managed care experience
  • Registered Nurse with current in-state RN license
  • UM or Case Management Certification
  • Interqual knowledge
  • Microsoft Access knowledge

Market Clinical Strategies Process Consultant Resume Examples & Samples

  • Model business consultation capabilities to align required needs with executable business solutions
  • Act as subject matter expert for Corporate Clinical Strategies Internal and External customers
  • Will manage oversight for Corporate Medicare Clinical Strategies programs: design, implementation, measurement and evaluation with internal customers, such as Provider operations. Humana Cares, and Regional Medicare Markets
  • Experience in leading health care initiatives
  • Progressive business consulting experience
  • Experience with process design and process improvement
  • MBA/MHA desirable
  • Business Development skills for Health Care Operations
  • Proven Track record with business development design/implementation
  • Provide process management support for HGO Clinical teams assigned to the Medicare markets
  • Provides support for business plan and long range forecasting model production by developing custom tools and reports
  • Develop a thorough understanding of Managed Care practices and procedures from a Medical Management perspective
  • Develop and maintain key working relationships across all HSO regions, HGO Corporate team and other departments to ensure consistent data tracking and reporting
  • Further the HGO’s vision for continuous improvement by assisting in identifying best practices in Humana’s Medicare Regions and formulating proposed solutions to address identified barriers
  • Identify and communicate system related enhancements to key stakeholders within Humana’s managed care departments
  • Bachelor's Degree in business related field
  • High level proficiency with Microsoft Office applications, including Visio
  • Excellent communication skills, written and verbal
  • Self-starter with a high level of accountability and a strong desire to excel in a fast-paced, high-demand environment
  • Previous health insurance industry experience working
  • Six Sigma Green Belt
  • Qlikview experience
  • Previous experience with Measurement Development
  • 50% Oversight with an emphasis on strategic planning, implementation and execution of relevant team and work stream plans for therapeutic indication(s) or company initiatives in keeping with corporate and department goals
  • Assess decisions from other functions and their impact on team and work stream plans
  • Provide updates and direction to Sr. Management when conflicts, key developments and program scope/ direction changes are identified
  • Work cross functionally to drive the strategy and oversee implementation for clinical programs or company initiatives
  • Identify and evaluate fundamental issues with multiple variables for major functional areas, and provides solutions and direction
  • Ensure document and operating standards are established and maintained locally and globally
  • Oversee selection of study sites and vendors
  • Participate in/ or lead cross-functional teams at corporate or global level
  • 20% Responsible for the creation and management of budget & forecast for specified therapeutic areas or company initiative
  • Overall responsibility for assigned clinical program budget(s) and LRP planning and implantation
  • Oversee budget activities
  • 20% Align skills and resources needed for success; work closely with internal and external stakeholders to leverage and optimize resources
  • Review and evaluate resource needs and influence for appropriate prioritization of clinical programs
  • Provide general direction to cross functional team representatives, as needed
  • Oversee management of sites and vendors to issuer resolution if necessary
  • Oversee identification, qualification and selection of CROs and vendors needed to conduct clinical trials and other relevant out-sourced activities including approval of Master Services Agreements and Task Orders with CRO
  • Align with team members from other functional arears regarding planning, implementation, tracking, analysis, and reporting of milestones
  • 5% Participate in business development and process improvement activities as needed
  • Under direction of Sr. Management, participate in due diligence activities
  • Establish/ identify the initiatives that will be targeted for improvement/ revision locally and globally
  • Participate in the development of corporate or organizational policies and authorizes the implementation
  • 5% Participation in Research and Development, a department and/ or corporate wide task forces as appropriate
  • Make outbound calls to providers in order to coordinate reviews/scanning of medical records of our Medicare Advantage members
  • Document all appointments scheduled and sending of fax
  • Assist the department with various clerical and administrative tasks
  • Assist in special projects as assigned by the department manager
  • Proficiency in Microsoft Office applications Word, Excel and Powerpoint
  • Puerto Rico Driver’s license
  • Reliable transportation
  • Ability to travel the island
  • Associate in a health related field

Clinical Global Development Team Lead Resume Examples & Samples

  • Lead the multidisciplinary Global Development Team(s) (GDT) and, if applicable, closely collaborate with the Product Strategy Team (PST) and the Product Strategy Team Lead (PSTL) to provide and execute strategic development plans to rapidly address key unmet medical needs and meet the strategic imperatives of the appropriate business unit (BU)
  • Matrix management of GDT members
  • Ensure all clinical documents have proper accuracy content,, CSR’s, Regulatory Documents, as the individual is ultimately responsible for overall strategy, tactics, and deliverables for the program
  • May lead one or two less complex development programs, and broadly contribute to strategic thinking at the Therapeutic Area level
  • Engagement and communication across business units and functional lines, including impact on strategic thinking at the Development Steering Committee (DSC) and the Pipeline Committee (PLC)
  • Partnership with Program Management (PM) representative on the GDT to ensure consistent high quality output from the team, and engagement with PM with regard to exploring opportunities to enhance speed and/or project value
  • Overall Development Strategy and Plan
  • Accurate and effective budget management for Development Programs, addressing issues as they arise
  • Assessment of Business Development opportunities which could impact on Development Programs, monitoring external scientific information and competitor activity related to Development Programs and modifying program strategy as appropriate
  • Tracking progress against project goals and composing monthly reports for senior management and Shire Leadership teams outlining key strategic events for projects. These documents contain program milestones, strategic imperatives, and financial information regarding projects
  • Responsibilities likely to include postmarketing commitments and lifecycle management initiatives
  • As an experienced Clinical Development professional, take a hands-on role in establishing a detailed clinical development plan, possibly working with a less experienced Clinical representative on the team
  • Be a lead clinical representative at key external business meetings (e.g. with regulatory authorities) and if appropriate, a presenter at regulatory Advisory Committee meetings
  • Line management and/or mentorship of less experienced GDTLs and/or Clinical research staff on GPTs
  • Be key point of contact for external key opinion leaders, and potentially media
  • M.D. preferred, or PhD, with experience managing Clinical Development projects in pharmaceutical or biotech company. Experience in small and large pharma and in different business models preferred
  • >8 years experience in the pharmaceutical/biotechnology industry
  • Experience of drug development in the TA where the position is focused, rare diseases, neuroscience, GI, or hematology would be preferred
  • Knowledge and understanding of regulatory requirements for product approval and compliance in US and Europe, experienced in global drug development
  • Aware of changing trends in pharmaceutical drug development, and experience in applying new approaches
  • Experience of team leadership in a matrix management environment
  • Experience with drugs at all stages of Clinical Development and presenting data to regulatory agencies/Advisory Committees. Experience in taking drugs to market preferred
  • Experience in modifying project plans and defining creative solutions to meet business needs
  • Troubleshooting and solving problems under very challenging timelines while maintaining standards of quality
  • Experience as an effective mentor. Line management experience preferred

Consultant for Clinical Audits Resume Examples & Samples

  • Maintains current working knowledge of ICD-9 and ICD-10 coding principles, government regulation, protocols
  • RHIA or RHIT or CCS credentials
  • 3+ years Acute Inpatient Hospital Coding experience
  • Demonstrated ability to lead process/project initiatives
  • MS Office proficient
  • Proficient 3M Coding and Reimbursement Systems
  • Preferred coding skills: prospective payment methodologies, auditing experience
  • Expected to resolve and/or escalate issues raised by assigned GCOL(s)
  • Collaborates with project physician, statistician and relevant functional areas on clinical trial designs
  • May attend advisory panel meetings and regulatory agency meetings related to strategy of program, indication, and studies
  • Presents program overviews/status to senior management, cross functional team, and external partners as necessary
  • Significant experience (10+ years) of clinical research and organizational management within the pharmaceutical industry, a CRO or similar organization
  • Demonstrated ability to present complex information to Shire management, vendors and external audiences
  • Ability to manage and communicate effectively with vendors including negotiating contracts, reviewing request for proposals, analyzing scope of work, responding to inquiries and complaints
  • Strong interpersonal skill set necessary to create and maintain internal and external collaborator relationships. Strong attention to detail and the ability to establish priorities for team
  • Aability to work independently, take initiative, complete tasks to deadlines and support assigned GCOLs in doing the same
  • Ability to work and influence others within a cross-functional team
  • Demonstrated ability to lead, motivate and mentor staff and teams
  • Develops project-plan(s) to achieve long-term goals based on higher business level drivers and strategies
  • Ability to work effectively wihtin a cross functional team
  • Demonstrated ability to create and manage 1 more program budgets including communication of overspend/underspend risk and mitigation efforts
  • Ability to communicate and influence key internal and external stakeholders to insure success while looking for opportunities for collaboration
  • Proven ability to removes barriers to success
  • Demonstrated ability to respectifully challenge current practices, decision or ideas to uphold quality or ethical standards
  • A demonstrated knowledge of the skills needed to deliver effective line management
  • Bachelor’s degree or several years of experience in a healthcare profession
  • Excellent data analysis and experience working with MS Excel
  • Familiarity with MS Access, Word and Visio

Mckesson Horizon Clinical Application Analysts Resume Examples & Samples

  • Horizon Expert Orders (HEO)
  • Horizon Order Management (HOM)
  • Horizon Emergency Care (HEC)
  • Horizon Clinicals Infrastructure (HCI)
  • Horizon Expert Documentation (HED)
  • Horizon Expert Notes
  • Horizon Expert Plans
  • Horizon Meds Manager

Clinical Innovation Consultant Resume Examples & Samples

  • Bachelor’s or Master’s Degree in Health Education
  • Current Bachelor’s or Master’s valid license
  • Proven successful experience in completing efficient research, with associated analysis and conclusions
  • Excellent PC skills (including MS Word, Excel, Publisher and Power Point) required
  • Excellent oral presentation, written communication and organizational skills required
  • Ability to travel Puerto Rico Island and Virgin Island
  • Personal car in good conditions and valid license
  • Team player, ability to work with tight schedules, extended hours, weekends, night shifts and multiples priorities
  • Ability to develop wellness programs, health conference, client presentations and experience in the health promotion impacting communities or diverse population
  • Master’s Degree in Public Health Education
  • Certified Health Education Specialist (CHES)
  • Certified Childbirth Educator
  • Certified Lactation Consultant or Certified Lactation Educator
  • Experience in managed care or health insurance setting desired
  • Experience in CCMS and SPSS Programs
  • Responsible for high quality clinical document deliverables across multiple, global assigned studies in support of CDO ensuring effective life cycle management of the clinical section of the Trial Master File (TMF)
  • Key contributor to the clinical study team
  • Monitors completeness and quality of the Clinical TMF, including elements outsourced to CRO
  • Oversees consolidation and archive preparation of clinical TMF, liaising with CRO partners to ensure compliance with company SOPs and timelines throughout the process
  • Ensures compilation of CSR appendices in accordance with Shire’s process
  • Collaborates with R&D contributors to define study specific TMF roadmap. Oversees the consolidation of the TMF across functions and external vendors at the end of the study
  • Supports inspection readiness for GCDO through periodic quality assessment of clinical records
  • Supports assigned TMF corrective action plans under direction of Snr CDT/Manager
  • Supports CDT led initiatives to enhance efficiencies in document management
  • Supports Managers in training efforts for new personnel
  • Demonstrated ability to be flexible and to adapt quickly to change

Clinical Guidance Specialist San Juan Resume Examples & Samples

  • Receive inbound calls to the providers in order to coordinate the pre authorization/discharge planning or concurrent review process
  • Work with providers to maintain updated of the pre authorization/discharge planning or concurrent review process
  • Work with the Clinical Advisor RN and support the pre authorization/discharge planning or concurrent review process
  • Complete provider outreach within specified timeframes to obtain standard patient clinical information for all patients identified for review, per program workflow and protocols
  • Complete updates to letters using the letters templates to support nurses and clinical leadership in sending the proper, timely correspondence to patients and providers
  • Complete required documentation and perform other responsibilities as necessary
  • Ability to quickly learn new systems
  • Proficiency in Microsoft Office applications Word, Excel and PowerPoint
  • Ability to work independently under general instructions
  • Good presentation and communication skills
  • Associate/University Degree

Clinical Strategies Analytics Consultant Resume Examples & Samples

  • Develop skills needed to access data from various internal systems and reports
  • Work closely with business subject matter experts to compile and track managed care metrics
  • Develop methods and criteria for summarizing metrics into appropriate reporting format
  • Communicate and lead strategy discussions across various departments around Medicare operational reporting
  • Complete special projects as needed
  • Advanced Microsoft Access skills
  • Clear written and oral communications skills
  • Previous experience with Medicare line of business preferred
  • Experience in using SAS, SPSS or Oracle preferred
  • Building dashboards using Qlikview
  • Ability to Reverse-Engineer a report in order to understand the process
  • Advanced SQL skills including the use of temp tables, data aggregation, linking multiple source tables, working with star-schema, synonyms and views
  • Bilingual – English/Spanish
  • 3 or more years’ experience in the health industry, to include knowledge of CPT code billing
  • At least one year of continuous service in current role
  • Develop an understanding of Humana’s business needs and translate those needs into technological systems, design specifications and solutions
  • Partner with other associates to analyze, design, develop, implement and integrate moderate and complex business systems that will optimize business outcomes
  • Bachelor’s Degree in Computer Science, Information Systems or equivalent experience (minimum of 3-5 years of experience)

Clinical Medicare Case Manager Resume Examples & Samples

  • Recommend services for Humana Plan members using care alternatives available within the community and nationally
  • Examine clinical programs information to: manage our members on an outpatient basis and develop strategies to prevent readmission; mine health risk assessment data reports to identify potentially high-risk membership; identify and refer members to Disease Management Programs; conduct discharge planning; coordinate Behavioral Health management
  • Coordinate: in versus out-of-network movement; care in out-of-network facilities; care with specialty networks; care with DME providers; transfers to SNF and back
  • Conduct post-discharge calls and discharge planning
  • Current RN or LMSW or LCSW license
  • 2-5 clinical experience preferably in an acute care, skilled or rehabilitation clinical setting
  • Valid drivers license and/or dependable transportation necessary (variable)
  • Special Certifications: Case Management Certification
  • Health Plan experience Previous Case Management experience
  • Medicaid/Medicare experience
  • Provides functional input into the clinical development plan that aligns with Business Unit and product strategy
  • Provides strategic clinical programs input to Global Development Team (GDT) and Product Strategy Team (PST) as required
  • Presents program/study(ies) overviews/status to senior management, cross functional team, and external partners as necessary
  • 30% Oversees or is responsible for
  • Program and /or study level document generation (e.g., synopses, ICFs, submission modules)
  • Presentations at relevant internal and external meetings
  • Alignment of program for cross functional team regarding execution
  • Reporting of program / study milestones including mitigation
  • Works closely with Global Development Team Lead (GDTL), finance business partner, and/or study team(s) to generate and review forecasts and accruals for clinical studies
  • Ensures clinical program/study(ies) finances align with agreed development plan, and budget variances are escalated to management as appropriate
  • May assess long-range resource needs and make recommendations and allocations across program(s)
  • Mentors junior staff
  • May be involved in interviewing, hiring, and training employees
  • Provides feedback on employee performance
  • Promotes Clinical Programs achievements within and across department(s)
  • Reviews and contributes to strategy for operational efficiency
  • Collaborates on SOP development
  • Ensures implementation and standardized use of Global Clinical Development Operations (GCDO) and/or other R&D tools.   

Clinical Trial Budget Analyst Resume Examples & Samples

  • Interacts with faculty, University offices and external funding agencies to facilitate the exchange of information and provide services associated with pre and post-award administration of contracts and grants to assigned department(s)
  • Acts as University representative to sponsoring agencies
  • Resolves pre and post-award administrative problems related to sponsored projects
  • Provides post-award administrative support including expenditure approvals, accounting detail and reporting requirement information. Monitors for allowability on contracts, submits interim reports, and reviews and approves closeout documents
  • Advises on specific agency requirements and guidelines to assist faculty in the preparation and submission of proposals
  • Composes and procedures a variety of business correspondence, reports, confidential documents and/or forms, and related materials or guides the work of other staff who produce these, materials. Reviews and signs, as authorized
  • Ensures confidentiality and controls access to sensitive information such as faculty or staff personal files
  • Assist in budget preparation by gathering historical data. Tracks and monitors assigned budget expenditures and/or special actions and reports on variances

Clinical Scientific Expert Resume Examples & Samples

  • Advanced Degree in Life sciences, Healthcare or a Clinically relevant field
  • Basic knowledge in planning, executing, reporting and publishing global clinical studies in a Pharmaceutical company or contract research organization
  • Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process
  • Exceptional Medical / Scientific Writing skills
  • Experience in Clinical Operations

Clinical Business Process Analyst Resume Examples & Samples

  • Technical experience in a Pharmaceutical or Clinical environment
  • Familiarity with associated tools such as Informatica Data Quality, JIRA ticket system and others
  • Experience in testing and validation system enhancements and bug fixes; responsible for associated documentation
  • Experience in identifying report issues and ability to troubleshoot and fix
  • Experience leading workgroups to gather business requirements
  • Solid analytical thinking skills
  • Prior experience managing clinical data within a Clinical Trials Management Systems
  • Experience working with Research & Development, especially Clinical Research & Development

Clinical Innovations Consultant Resume Examples & Samples

  • Bachelor Degree in health or relevant working experience
  • Experience with utilization management of Medicare and/or Medicaid population/plans
  • Proven successful experience in completing efficient health-related legal, compliance or regulatory research, with associated analysis and conclusions
  • Experience with Medicare and Medicaid compliance and regulatory requirements
  • Registered Nurse with at least 3 years clinical experience with Medicare and Medicaid populations
  • Master’s degree in health- or business-related field
  • Likes to focus on the “big picture” and thrives in a fast paced work environment
  • Able to work interactively with internal and external business partners
  • Self – starter and problem solver
  • Intermediate knowledge of Microsoft Word, Excel, PowerPoint
  • Ability to utilize analytical thinking in determining root cause
  • Exhibit high level of emotional intelligence
  • MS Access reporting experience
  • Knowledge of CAS and or MTV claims system including processes and adjustment experience

Stars Clinical Task Force Data Analyst Resume Examples & Samples

  • Analyze and monitor production data in comparison with aggregate and contract goals
  • Analyze data to "Tell the story"; identity trends and key areas of improvements for clinical Stars measures
  • Develop timely clinical measure reporting
  • Compile geographical and contract level insights to inform initiative planning and/or revisions
  • Manage special projects supporting Stars Clinical Taskforce initiatives
  • Maintain Stars process discipline from Clinical Task Force team (manage SharePoint, maintain project plans, update initiative briefs, etc.)
  • Maintain strong working relationship with internal stakeholders
  • Plan all Stars related events including quarterly Stars Planning Meetings
  • Coordinate Task Force Tuesday meetings
  • Comprehensive knowledge of all Microsoft Office applications such as Microsoft Word & PowerPoint
  • Must be able to do the following in Excel: Must be able to analyze large data sets
  • Excellent communication skills due to high exposure across Humana
  • Experience interpreting and leveraging data in effective decision making
  • Ability to self-motivate and provide self-direction/self-starter
  • Ability to do the following in Access: Must be able to run complex queries in Access, such as Cross Tab Queries and Query Joins
  • Experience with database queries
  • Prior work experience in the healthcare industry
  • Process mapping and process management experience
  • Visio / Process Mapping

Clinical Modeling Consultant Resume Examples & Samples

  • Degree in mathematics, biostatistics, computer science, engineering, public health or equivalent work experience
  • 3-5 years of coursework and/or commensurate professional experience with analysis and outcomes
  • 3-5 years of experience using technical and analytical tools (e.g. SAS/SQL) to manipulate and draw insights from large, complex data sets
  • Previous experience creating a research/analytical plan, completing in-depth analysis on large data sets, and communicating the outcomes or findings to others
  • Clear verbal and written communication with the ability to communicate analytical data and insights to a wide variety of consumers
  • Ability to work efficiently to manage multiple competing projects and initiatives
  • Flexible, dynamic personality who works well in a team environment and is also an individual contributor
  • Masters’ degree in health services research, statistics, quantitative social science or related analytical focused field
  • Advanced understanding of medical claims data including the use of medical coding to identify relevant populations based on clinical criteria
  • Experience reporting on the healthcare utilization patterns of discrete populations from claims data
  • Project management experience or demonstrated skills managing large projects and pulling together multiple resources
  • Understanding of managed care data, benefit design and how it applies to clinical research
  • Experience in forecasting and predictive modeling techniques

Clinical Assessment Developer Resume Examples & Samples

  • Participate in developing and refining test items and working with the Research Director and others on test content and format
  • Develops item art specifications and works with the Design, UX, and Production teams to ensure that visual and verbal item stimuli meet both print and software specifications and usability standards
  • Conducts literature reviews, compiles references, and collects supporting face pages
  • Responsible for preparation of scoring materials, training scorers to accurately score test protocols, monitoring the accuracy of the scorers’ work, and retraining if necessary
  • Executes different research phases of the project which may include finalizing record forms, stimulus books, and manuals, writing chapters of the final manual using standard text templates, providing necessary content information for scoring and reporting software programs, and checking for consistency across different components of the test
  • Works with the project team to ensure that all test kit materials and deliverables, both in print and digital mediums, are prepared in a timely manner to meet the publication schedule
  • Masters in School Psychology, or PhD or PsyD in clinical, counseling, or school psychology
  • Must have demonstrable expertise, training, and clinical experience in the area of psychological assessment, as well as interest in applying aforementioned expertise, experience, and skills to the development of published print and digital clinical assessments
  • Must have a minimum of 1 year clinical/educational/research experience involving administration and interpretation, and/or development of clinical assessment instruments
  • Must have strong oral and written communication skills, good planning and organizational skills, interest and training and/or basic graduate level skills in research methods and statistics, ability to work as part of a team, flexibility, and desire to learn the test development and publishing process
  • Good familiarity with basic computer software programs (e.g., Word, Excel) and the ability to use or learn digital communication tools such as video conferencing
  • Subject Matter Expertise:Expertise in psychological assessment, training and/or experience in research, and practical experience in both psychological testing and intervention
  • Teamwork: ability to work collaboratively as part of a multidisciplinary project team with software engineers, designers, user experience experts, editors, marketing professionals, etc
  • Critical Thinking: ability to recognize assumptions, evaluate arguments, and draw conclusions that are clear, consistent, sound, and fair and result in positive outcomes for the business
  • Comfortable with technology in business, with experience, skills, and/or demonstrated ability to utilize and/or teach others to utilize technology, mobile and web applications, and software in everyday life and in business
  • Experience creating an app or prototype
  • Experience creating digital assessment tasks or games
  • Experience conducting research with digital tests or games
  • Basic knowledge of XML or HTML

Epic Certified Clinical Specialty & Ancillary Analyst Resume Examples & Samples

  • Current Certification in one or more of the areas listed above with at least 1 year of hands on build experience
  • Actively participated in all phases of the Epic deployment process (Design, Build, Validate, Implement, and Optimization)
  • Will be responsible for managing and leading automated system projects through all phases of the system development life cycle. This includes design, development, implementation, modification, planning, estimating, feasibility testing and evaluation of automated systems
  • Will make recommendations and provide input to the Client concerning software evaluations
  • Provide best solutions to identified needs, meeting operational and business objectives, and technology capabilities
  • Maintain the ongoing service relationships between the Information Technology Department and its direct application customers, and is a liaison to other departments and entities
  • Will provide after-hours support and other duties as directed by Client
  • This position supports one or more Epic module/tool/add-on system. The Analyst will take the lead role in the project planning, design, build, implementation and ongoing support for the new Epic use at the client facility or facilities
  • Both clinical workflow and technical build experience required
  • Bachelor’s Degree preferred or equivalent professional experience
  • 1 - 3 years relevant healthcare information systems experience required
  • Strong knowledge of project management methodologies and experience managing multiple projects

Clinical & Technical Specialist Mena Resume Examples & Samples

  • Maintains open and effective communication with all personnel, customers and other Company employees
  • Contributes to the completion of milestones associated with specific projects at the regional level
  • Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high quality work

Clinical Trial Transparency Lead Resume Examples & Samples

  • 50%:Assists Team Lead in Internal and External Transparency and Data Sharing Projects and Strategic Transparency Initiatives
  • To develop a sustainable, end-to-end process to fulfill Shire’s commitment to responsible and ethical approach to trial disclosure and transparency across the organization
  • Supports and Consults with internal core team and/or sub-teams on strategic transparency initiatives
  • Provides compliance expertise and technical guidance to internal staff and senior management on an ongoing basis
  • Maintain awareness of changes in the Transparency landscape, including both regulatory requirements and industry trends
  • Assesses impact, identifies action required, and communicates needs to CTT management
  • Collaborates with CTT team to ensure a firm understanding of the activities affecting transparency
  • Assists CTT Team Lead in external initiatives to represent the company position in support of transparency activity and development of industry standards
  • Develops materials targeted to various internal and external audiences to communicate the overall Transparency/Data Sharing Strategy
  • Creates Training materials and presentations for key functional areas and at all levels of the organization
  • Proposes and assists in activities that support evolving strategy for clinical trial transparency
  • 40%: Process and System Development
  • Supports the CTT Team Lead in preparation of materials for committees and cross-functional Working Groups as needed
  • Assists CTT Team Lead to establish strategy and policy, develop and implement processes, and ensure compliance with global disclosure requirements
  • Develops and maintains processes and systems to optimize efficiency, maximize content reuse and ensure quality
  • Evaluates trends and identifies areas for improvement. Supports CTT Team Lead in process analysis efforts and identifies opportunities to improve efficiency and effectiveness
  • Works cross-functionally and collaborative to evolve global transparency processes, procedures, performance measures, systems and communication
  • Develops global training strategy for transparency processes
  • Mapping of “as-is” processes and proposal of “to-be” processes
  • Develops policy based on Shire corporate position on Transparency
  • Develops best-practice processes to centralize, expand and optimize each area
  • Develops workflow and updating SOPs to support new processes
  • Establishes a communication plan to bring awareness and cooperation across contributing functions
  • 10%:Support operational oversight and overall strategy for Aggregate Spend Reporting
  • Collaborates with required cross functional team to develop department- specific data collection processes
  • Supports data collection and formal reporting activities for Global Clinical Development Operations
  • Coordinates monthly submission into Shire’s reporting database
  • Bachelor's or Masters degree in scientific or related field is required; advanced degree is preferred
  • Knowledgeable of Global Clinical Trial Transparency and Data Sharing requirements preferred
  • Strong comprehension of GCP, ICH guidelines, and applicable regulatory requirements

Clinical Project Associate Resume Examples & Samples

  • 1+ year of experience with Clinical Study planning, execution, reporting or publishing activities
  • Bachelor's Degree or equivalent education / degree qualification in Life Science / Healthcare
  • Previous experience at a local Medical organization, Investigational Site, Pharmaceutical company / CRO, or Clinical Fellowship Program

Integrated Clinical Solutions Resume Examples & Samples

  • Manage a team of project managers, consultants and analysts who are responsible for the project management, resource allocation and pipeline management of all projects related to Clinical Systems development
  • Engage with leadership in all functional areas, driving integrated IT planning throughout the business
  • Present professional communications to executive leadership in order to educate and influence opinions
  • Serve as a program expert across multiple projects, planning, managing, monitoring and implementing technology solutions in a variety of business contexts and maintaining a forward-looking perspective with regard to technological developments
  • Management/leadership experience with multiple accountabilities for budget and operations across diverse organizations, managing direct reports, including building human capital, managing daily workload, performance evaluations and timesheets, managing career development for employees
  • Business and technical product selection, and practical implementation of IT solutions
  • Collaborating and successfully fostering relationships with business executives, both internal and external, in order to achieve desired results, communicating with high level senior leadership, and problem resolution under tight deadlines
  • PowerPoint, Excel, Word, MS Project, and Visual Source Safe
  • Program and Project Management - Configuration Management, CMM/CMMI methodologies
  • Software testing and software releases, release management and release oversight
  • Oversight of testing, including compliance , testing, and verification of claims within multiple large scale environments and projects
  • UAT Processes and Procedures; and
  • Maintaining longevity with vendors and managing vendor expectations

Clinical Programs Group Lead Resume Examples & Samples

  • Accountable as the group lead by providing oversight to one or more Global Clinical Operations Lead(s) (GCOLs) and/or their associated programs,
  • Provides direction on strategic and operational issues in support of these programs
  • Serves as the point of contact for the Head of Clinical Programs for all clinical programs assigned
  • Provides functional input into the clinical development plans that aligns with R&D and Business Unit strategy
  • Provides strategic clinical programs input to the development/strategy team as required
  • Co-leads the Development Operations Team (DOT) with the Global Clinical Development Lead (GCDL)
  • Has in-depth knowledge of global regulatory/industry guidelines (e.g. ICH/GCP, promotional guidelines and labeling) to drive the clinical trial application process
  • Effectively represents the interests and perspectives of GCDO
  • Co-leads inspection readiness activities, and acts as subject matter expert during regulatory inspections
  • Bachelor’s degree or nursing qualification is required. Scientific/healthcare field preferred but not required. Advanced degree preferred
  • Previous line management or direct management (3+ years) of team members
  • Participation in marketing application review and submission
  • Experience managing financial budgets

Clinical Guidance Analyst Resume Examples & Samples

  • Experience in analyzing data and making recommendations to aid in decision making
  • Degree in Business, Engineering, Math, Health Administration, Accounting or related field
  • Excellent programming skills desired (SAS or SQL preferred)
  • SQL, SAS, Qlikview experience
  • Experience in HEDIS data analytics desired
  • Prior experience working with physician practice management systems desired
  • Certified medical billing coder desired

Clinical Systems & Technologies Analyst Resume Examples & Samples

  • 10%: Maintain and administer Clinical systems as needed
  • 20%: Vendor set up and CRO oversight
  • 35%: Provide analysis in support of process improvement of Clinical Systems. Participate in projects to enhance clinical systems/processes. Define end user requirements and support. Provide administration support; manage permissions and security and recommendations for all issue/enhancement requests. Hands-on training support as required
  • 30%: Collaborate with Process Optimization team and IT on system enhancements and roll out of changes/enhancements, including development of training materials/user manuals/learning solutions
  • 5%: Responsible to interact with various levels in the organization including IT support for Senior Management
  • Bachelor’s degree (scientific, business or technical degree)
  • A total of 5 years of related work experience of which 3 should be in the pharmaceutical industry
  • Prior experience with Clinical Systems is highly preferred
  • Experience working as a liaison between IT and Clinical
  • Experience with IVR/IWR technologies
  • Understanding of Clinical data and how to present the data in a meaningful way
  • Experience with SDLC
  • Strong team, computer and analytical thinking skills
  • Individual must be self-motivated, effective follow-up skills and a demonstrated ability to respond to issues of a global nature is important
  • Strong organization skills and attention to detail are critical
  • Ability to work with changing priorities
  • Ability to communicate technical concepts with all levels of the organization

R&D IT Head for Clinical & Pharmacovigilance Resume Examples & Samples

  • Develop and deliver support in accordance with Service Level Agreements based on business requirements. Work closely with business partners in understanding and responding to both long-term and short-term R&D Clinical and Pharmacovigilance goals and strategy
  • Strengthen the delivery of transverse R&D Clinical and PV services, building or leveraging shared applications services
  • Deliver transverse analytics capabilities and leverage to support the mission of the R&D Clinical and PV organizations
  • Collaborate and negotiate with external partners to support system operations development / integration, ensuring reliability, competence, flexibility and cost effectiveness
  • More than 10 years relevant IT/Business experience managing and / or directing technology projects, including technology operations and the management and delivery of technology solutions. (required)
  • More than 10 years relevant IT experience managing/overseeing a Pharmaceutical R&D functional systems domain (i.e. Clinical, Regulatory, PV) and strong knowledge of IT Computer Systems Validation processes. (required)
  • More than 8 years of IT management experience and familiarity working in complex, global matrix organization (preferred)
  • M&A Experience (required)
  • Experience with Clinical and post marketing safety suites and specifically Oracle/Argus and including safety database, case processing, periodic submissions and also safety signal management (required)
  • 30%:Delivering Excellence: Takes leadership role in standards project implementation
  • Acts as Standards area project manager for selected standards projects. Establishes and maintains project plans and effectively articulates them; defines risks and recommends contingency plans as required
  • Mentors team members, junior staff or contractors via matrix relationships or direct supervision, in standards implementation, optimal usage and by directing work, resolving problems and/or providing guidance
  • Owns, governs and maintains designated GCDO developed standards models (including but not limited to: SDTM, CDASH, Terminology, ADaM, TFLs, document templates, questionnaires). Includes periodic assessment of standards content with respect to compliance and industry impacts
  • Leads assessment, implementation, integration and governance of systems and tools to support, manage, govern and report on standards
  • Conducts standards compliance review and works with functional areas and strategic service providers to reinforce content and interpretation of Shire standards.Collaborates closely with CROs/Strategic service providers to ensure appropriate management, training and deployment of Shire’s standards within the service provider’s infrastructure
  • Represents Shire and Global Clinical Development Operations as a member of SDOs or Standard Support Groups (e.g. CDISC, PhUSE)
  • Leads the assessment of updates and/or suggested enhancements to the standards library, standards knowledgebase/governance portal, OpenCDISC and other applications. Coordinates with IT where necessary
  • Contributes to the GDCO metadata standards management strategy and leads associated projects or initiatives
  • Contributes to budget forecasting and resourcing requirements. Reviews proposals and participate in the selection of service/technology providers. Manages contracts and statements of work
  • 20%: Accountability and Ownership: Drives accountability at every possible level
  • Collaborates with Standards Team lead to identify and resolve issues impacting goal attainment. Leads resolution efforts
  • Contributes to the standards education and training strategy both internal and external. Develops and delivers training programs to affected internal and external staff
  • Ensures CRO/strategic service providers and Shire are deploying standards and leveraging them across the organization at an enterprise level
  • 20%:Judgment and Decision Making: evaluates immediate business impact and takes decisive action
  • Stays current with changes in the external standards landscape and strategies, including requirements from regulatory authorities and agencies, and leads the development of recommendations for actions. Co-ordinates responses to provisional regulatory agencies standard requirements or requests for input or provisional SDOs documents
  • Continually assesses and makes recommendations on the standards deployment strategies and activities at the CRO/strategic service providers to ensure optimal benefit for Shire
  • 15%: Serving Customers: Partnering with customers as a trusted consultant and becoming an integral part of customer’s decision making
  • Actively works with R&D functional areas to develop and manage standard documents and the reporting of related standards
  • Consults within and across Global Clinical Development Operations, and the CROs/strategic service providers to identify gaps, risks and inefficiencies and works with Standards Team Lead on solution development. Leads the implementation of the agreed solutions
  • Represents Global Clinical Development Operations in cross- functional standards and coding project teams
  • Interfaces with Global Clinical Development functions to ensure optimal process design leveraging standards infrastructure and scope
  • 15%: Building Authentic Relationships: Building trusting relationships that will enhance current and future needs
  • Establishes and fosters strong collaborative relationships with strategic partners and service providers around performance, delivery, quality, innovation, and value
  • Coordinates with Standards Team Lead and peers to prioritize, and lead standards related initiatives
  • Manages the activities of standards management vendors. Ensures adherence to agreed specifications, timelines and budgets
  • Minimum 8-10 years in Data Standards or Data Management or Programming or Statistics. Strong working knowledge of CDASH, SDTM or ADaM, and CDISC controlled Terminology
  • Knowledge of XML preferred
  • Experience with leading teams and/or organizations
  • Experience with SQL coding
  • Excellent organizational skills required
  • Advanced degree in Business, Health Administration, Computer Science, Accounting or related field
  • Resides within the New York Metropolitan area
  • Team Player with experience working with Clinical Associates

Clinical Guidance Technology Consultant Resume Examples & Samples

  • Offer second tier support for issues arising from the use of enterprise standard applications such as Microsoft Office and Project
  • Assist in the administration of routine tasks including zoning, masking and space monitoring, and new initiatives such as remote data replication and policy-based archiving
  • Create the documentation necessary to distribute applications to the desktop and server platforms
  • Provide ongoing technical advice, assistance, and training to fellow associates and to customers
  • Bachelor’s Degree in Information Technology or Computer Science, or equivalent experience
  • Working knowledge of the database technologies
  • Experience in MS-Access and SQL
  • Microsoft certification

Clinical Due Diligence Team Lead Resume Examples & Samples

  • Leads the GCDO team strategy and approach for in pre-due diligence and due diligence for both in-licensing and merger and acquisition opportunities
  • Build and sustain a highly respected GCDO due diligence team that works cross functionally and across therapeutic areas aligning strategy and operational execution, to support Shire in making informed decisions on business opportunities
  • Lead GCDO due diligence team in close partnership with GCDO internal teams to ensure seamless knowledge transfer and integration of acquired assets
  • 40%: Pre-Due Diligence
  • Oversee GCDO participation and inputs for the pre Due Diligence Team, to evaluate target opportunities up to the decision point of progression to due diligence
  • Lead GCDO sub team in the generation of scenario generation consistent with the target product profile (TPP), generating clinical costs, enrollment assumptions, statistical assumptions, trial designs consistent with regulatory and commercial strategies, GCP and vendor assessments, operational feasibility and data analysis
  • Lead or co-lead the R&D sub team in the generation of visual development plans, project assumptions, key findings, probability of success estimates and full R&D costs
  • Oversee the request and review FTE inputs
  • Ensure the quality and consistency of all inputs provided to corporate finance in support of the valuation
  • Conduct pre-DD site visits as needed
  • Ensure concise written reports are provided as needed
  • Ensure endorsement and alignment with GCDO leadership for all assumptions and activities
  • 40%: Due Diligence
  • Oversee GCDO participation and inputs for the Due Diligence Team, to evaluate target opportunities up to the decision point termination or progression to a business transaction
  • Lead GCDO sub team in the generation of scenario generation consistent with the target product profile (TPP), generating clinical costs, enrollment and statistical assumptions, trial designs consistent with regulatory and commercial strategies, GCP and vendor assessments, operational feasibility and data analysis
  • Lead or co-lead the clinical sub-team to refine trial designs, data analysis and other clinical issues
  • Support program management in the generation of visual development plans, project assumptions, key findings, probability of success estimates and full R&D costs
  • 15%: Integration
  • Participate and provide inputs to the Clinical Integration Team, to ensure seamless knowledge transfer for all acquired assets
  • Ensure GCDO provide timely, high quality inputs for: human resource, IT, transition cost and portfolio decisions
  • Ensure continuity of all core expertise for key products, people and technologies
  • Communicate and support Integration team to facilitate synergies as quickly as feasible without compromising development or commercial performance
  • 5%: Build and maintain GCDO Due Diligence Department
  • Assess short-term and long-range capabilities and resource needs
  • Develop and sustain quality feedback mechanisms to ensure the GCDO team is delivering consistent high quality outputs and working collaboratively on all teams
  • Make recommendations and allocations across projects
  • Serve as a role model for Shire Brave values within Clinical Operations
  • Line management of Clinical Due Diligence staff
  • Minimum Bachelors degree in a scientific discipline is required
  • Minimum 15 years experience of clinical research and organizational management within the pharmaceutical industry, a CRO or similar organization is required
  • Experience in problem solving, negotiations, presentation and collaborative team-building with non-direct reports required
  • Previous line management or direct management of team members required
  • Experience of global regulatory requirements required
  • Valuation, Commercial Assessment, Financial and business understanding required

Clinical Trial Project Associate Resume Examples & Samples

  • Solid mathematical, statistics and/or analytical skills
  • Degree in Mathematics / Statistics and or Computer Science / Information Technology
  • Experience in Clinical Research / Regulatory processes
  • Knowledge of Process Improvement Methodology

Clinical Engineering Manager Resume Examples & Samples

  • Hires, places and trains technicians and other staff within the CE department, and administers coaching, delivers performance feedback and issues discipline to direct reports
  • Establishes work priorities and provides daily supervision and support to all assigned staff
  • Ensures compliance with all Joint Commission/DNV and OHSA regulations and other local, state, and federal government regulations
  • Provides counsel to client regarding purchases of new capital equipment
  • Minimum of 5 years experience in related field, with at least 3 years of supervisory experience

Clinical Engineering Director Resume Examples & Samples

  • Requires a minimum of a bachelor’s degree in Biomedical Engineering, Electronically Engineering Clinical Engineering, Mechanical Engineering, or Information Technology w/concentration in Security or Physics
  • Master’s degree strongly preferred
  • 5 years minimum experience required
  • Certifications or license desirable in one or more of the following: PM, CISM, EIT, PE and CCE
  • Requires proficiency with a PC and all Microsoft Office software, including PowerPoint, Excel, Access, Project, and Word, as well as mathematical analysis packages, etc

Clinical Resume Examples & Samples

  • Market level development, implementation and oversight of Clinical Innovation Outreach Specialist staff
  • Coordination of management efforts with other Humana departments including, but not limited to Health Services Onsite Staff, Case/Disease Management, Quality Improvement, and Provider Relations
  • Collaborate with Health Services Manager for data collection, reporting and Quality Improvement initiatives on all programs, including evaluating ongoing effectiveness and improvement opportunities
  • Provides daily oversight and guidance to non-clinical support staff
  • Maintain proactive communication with other departments to ensure efficient, accurate and timely responses to internal/external customer needs
  • High School Diploma or current LPN license in state of Florida with no restrictions
  • Sales and/or Customer Service experience
  • Proficiency in all Microsoft Office Programs, e.g. Word, PowerPoint, Excel, Access, etc
  • General understanding of economic, financial and operational concepts
  • Medical Terminology knowledge or Clinical experience

R&D IT Head for Clinical Resume Examples & Samples

  • Develop and deliver support in accordance with Service Level Agreements based on business requirements. Work closely with business partners in understanding and responding to both long-term and short-term R&D Clinical goals and strategy
  • Strengthen the delivery of transverse R&D Clinical services, building or leveraging shared applications services
  • Deliver transverse analytics capabilities and leverage to support the mission of the R&D Clinical organizations
  • Bachelor's Degree in the field of Information Technology, Engineering, Computer Science or a related study. (Master’s degree preferred)
  • More than 8 years working in the Pharmaceuticals or Life Sciences industry (preferred)
  • Experience with Clinical systems (e.g. Trial Mgmt, Data Mgmt, Medical Writing, Clinical Supplies, Biostat/Statistical Programming, Analytics and Reporting, eTMF, investigator portal, etc…) (required)
  • Experience with budgeting, planning, ROI/NPV model development, and IT governance

Clinical Intelligence & Analytics Associate Actuary Resume Examples & Samples

  • Associate of Society of Actuaries (ASA) designation
  • Meets eligibility requirements for Humana’s Actuarial Professional Development Program (APDP)
  • Advanced Technology Skills
  • Ability to certify statements of Actuarial opinion
  • Ability to translate technical issues to staff and manager
  • Project management capability - able to plan and organize work for self and others on a team
  • Experience in more than one discipline (e.g., modeling, pricing, rate filing, reporting & analysis, reserving or trending)

Biostatistics Team Lead-registries & Clinical Resume Examples & Samples

  • Serves as therapy area leader within biostatistics; interacts with project and product strategy teams and communicates therapeutic area plans and strategy to subordinates
  • Directs activities for selection of appropriate statistical methods for analysis of clinical study data; provides input into clinical development plans, approves clinical study reports and integrated summaries of safety and efficacy
  • Responsible for interacting with FDA personnel on clinical trial statistical issues in the design, analysis of clinical trials, design of other study types, and data presentations
  • Reviews regulatory documents such as CSRs, as well as summary documents
  • Consults with the Medical Writer and Physician on the interpretation of efficacy results
  • Contributes to the publication plan. Reviews abstracts, posters, and manuscripts to support Medical Affairs
  • Lead departmental process improvement initiatives and contribute to SOPs
  • Contributes to the establishment and maintenance of common formats and templates for key Biometrics documentation (e.g., statistical section of protocol, standard CRF pages, Statistical Analysis Plans, Tables, Figures and Listings). Contributes to the design of standards for SAPs
  • Directs outsourcing activities in collaboration with preferred vendors. Provides strategic and tactical input in the contracting with Global Biometrics preferred providers
  • Identifies the need for contractors and supervises contractors to support projects
  • Responsible for hiring, planning and assigning work, setting objectives and development plans, appraising performance, giving performance related feedback and rewarding and recognizing employees
  • M.S. in Biostatistics or closely related field is required
  • Ph.D. in Biostatistics or closely related field is strongly preferred
  • Generally has 10+ years of relevant pharmaceutical experience with 5+ years of supervisory experience
  • Strong background and working knowledge of statistical methods that apply to all phases of clinical trials and other study designs. Must have a working knowledge of statistical analysis plans including the report outline, mockup tables, graphs and data listing shells and appendices
  • Must have a working knowledge of all appropriate relevant regulatory guidance documents (e.g. ICH, FDA and EMEA)
  • Direct regulatory filing experience is required
  • Some people management experience strongly preferred
  • Proficiency in SAS is strongly preferred
  • Ability to help others understand the broader business and organizational context (inspiring and motivating others)
  • Demonstrated ability to deliver excellence by integrating planning efforts across departments or organizational boundaries to ensure organizational effectiveness (delivering excellence)
  • Demonstrates a customer focus by partnering with customers as a trusted consultant and serves as an integral part of customer’s decision-making process (serving customers)
  • Demonstrated ability to reinforce a culture in which partnering is a norm (global and cross-boundary communication)
  • Demonstrated ability to accept responsibility for individual and team performance (accountability & ownership)
  • Demonstrated ability to evaluate the business impact of decisions and remains committed to following through on agreed upon decisions yet remains flexible should priorities change (judgment and decision making)

Clinical Intelligence Actuarial Analyst Resume Examples & Samples

  • Apply expertise and technical support, under the guidance of seasoned associates, in matters related to the successful and financially sound operation of the company’s business to the department’s external and internal customers
  • Develop a library of metrics, methods, processes and reports in support of clinical strategy and development
  • Research and identify trend drivers
  • Collaborate with fellow team members as well as build productive cross-functional relationships within multiple areas of the organization
  • Working knowledge of Microsoft Excel, Visual Basic, and some database application (e.g., Access or SQL)
  • Leadership in extracurricular activity
  • Demonstrated learning agility

Clinical Intelligence Associate Actuary Resume Examples & Samples

  • Ownership of our Medicare Outpatient Early Indicator Report. This involves advanced SAS coding knowledge and an understanding of how to create completion factors and apply them to the claims data. This report drives our emerging trend findings to senior leadership
  • Maintenance of the completion model and reviewing monthly restatements
  • On point for any drilldown analysis related to this report that could involve claim line level research
  • Communicating results to our customers, which could include any number of people ranging from regional analysts to senior leadership
  • Handling ad hoc requests as necessary
  • Advanced technology skills, including Excel and computer programming language such as SAS or SQL
  • Team building skills
  • SAS Coding Experience

Clinical Engineering Technician Resume Examples & Samples

  • Works with an experienced BMET in the installation, maintenance, and repair of biomedical equipment
  • Consults with higher level authority for resolution of difficult issues
  • Conducts departmental rounds with customers to promote communication and learn operations
  • Repairs, tests and calibrates equipment according to manufacturers’ recommendations and other established guidelines
  • Performs assigned duties in accordance with current policies and procedures, including equipment inspection, minor repairs and planned maintenance, all under the appropriate supervision
  • Assists in the ordering of parts and supplies necessary for the servicing of medical equipment
  • Completes assigned work in a timely manner
  • Prioritizes work load effectively
  • Shows initiative, follows established procedures, and works in a safe manner
  • Maintains timely, accurate and thorough documentation required by management, as outlined in current policies and procedures
  • Demonstrates initiative and concern for planning, time utilization and cost containment
  • Possesses knowledge of electrical safety theory, and performs electrical safety testing on biomedical instrumentation
  • Computer skills (MS Word, Excel, Outlook required)

Clinical Market Intern Resume Examples & Samples

  • Explore application of medicine to engineering, to understand key requirements in medical device development
  • Review medical and scientific literature to refine clinical needs
  • Participate in product concept generation activities, and conduct expert interviews
  • Review market research and competitive landscape to evaluate market size and define value proposition for innovative medical technology
  • Education: Medical related discipline, preferably in the final years of MBA program
  • Knowledge: understanding of medicine and management, with clinical experience
  • Skills: Able to interact with a multidisciplinary team of engineers and researchers. Excellent oral and written communication skills with the ability to communicate clearly to others in different functions, at various levels

Stars Clinical Task Force Consultant Resume Examples & Samples

  • Implement member and provider initiatives to improve Clinical Stars and Medicaid Quality scores
  • Work with Stars Divisional Consultants to determine the appropriate approach with the markets and identify recommendations/plays to drive rate improvement
  • Collaborate with vendors and other key stakeholders to develop relationships, resolve issues, and promote mutually beneficial strategies and processes
  • Activate coordination and engagement with key internal stakeholders that provide services and support to Humana and/or directly to members
  • Identify and evaluate data trends and determine the impact to Quality rates
  • Demonstrate ability to "tell the story" of each initiative demonstrating action plans and results
  • Ability to interpret and leverage data to improve strategy
  • Ability to use data to create, implement and track new initiatives
  • Excellent PC skills (including MS Word, and Excel)
  • Experience managing medium to large scale projects and or initiatives in a fast paced environment
  • Experience viewing data utilizing ClikView

Clinical Auditing Analyst Resume Examples & Samples

  • RN, LPN, or Certified Coder
  • Training/Facilitation experience (classroom and virtual)
  • Experience in guideline creation to include Visio flows
  • Excellent organizational skills desired
  • 2+ Years broad clinic experience
  • 3 or more years’ experience in the health industry, to include knowledge of
  • CPT code billing
  • Experience in quality auditing

Clinical Trial Operations Manager Resume Examples & Samples

  • 10+ years of experience in pharmaceutical industry or clinical-related discipline
  • 7+ years clinical research experience
  • 4+ years of strong trial operations management experience
  • Responsible for the strategic and operational oversight, management, and delivery of a clinical development program or study in support of Shire’s project strategy team
  • Authors, provides input, and/or oversees program and/or study level documents
  • Manages clinical outsourcing and may represent Clinical Programs on vendor oversight committees
  • Manages financial aspects of asssigned clinical program or study(ies) and provides to Development Team Lead
  • Responsible for strategic initiatives for process and business improvements
  • 30%: Oversees or is responsible for
  • Significant clinical research experience (8+ years) with evidence of increasing responsibility within a pharmaceutical company or CRO

Clinical Evaluation Manager Resume Examples & Samples

  • 3+ years of Utilization Review experience at a Managed Care Organization or Health Plan
  • Bachelor's or Master's Degree in Nursing
  • Exceptional documentation and clinical skills
  • Excellent communication skills (written and verbal
  • Certified Case Manager
  • Knowledge of Medicaid and/or Medicare regulations
  • Knowledge of Milliman criteria (MCG)
  • 3+ years of previous experience working within a Managed Care or Health Plan organization
  • Microsoft Office/Suite proficient (Excel, PowerPoint, and Word)
  • 2+ years of experience in Utilization Review
  • Certified Case Manager certification
  • Strong cost containment / case management
  • Knowledge of Medicare/Medicaid and/or commercial regulations
  • 50%: Oversight with an emphasis on strategic planning, implementation and execution of relevant team and work stream plans for therapeutic indication(s) or company initiatives in keeping with corporate and department goals
  • 20%: Responsible for the creation and management of budget & forecast for specified therapeutic areas or company initiative
  • 20%: Align skills and resources needed for success; work closely with internal and external stakeholders to leverage and optimize resources
  • Align with team members from other functional areas regarding planning, implementation, tracking, analysis, and reporting of milestones
  • 5%: Participate in business development and process improvement activities as needed
  • 5%: Participation in Research and Development, a department and/ or corporate wide task forces as appropriate
  • Bachelor’s degree in life sciences, nursing, medical device –related area or equivalent college program required; Master’s preferred
  • Minimum 10 years clinical research or medical device/IVD program experience
  • Minimum 3-5 years project management experience in clinical research or medical device programs, including leading and/or managing staff directly
  • Advanced understanding of the design, development, and execution of clinical and development programs related to medical devices/IVD’s. Works on abstract problems
  • Demonstrated ability to handle multiple programs and/or therapeutic areas associated with a high degree of complexity; known as effective resource for organization on clinical methodology issues, drug development, process improvement initiatives and people management
  • Ability to synthesize complex medical and scientific information through demonstration of effective written, verbal and presentation skills to all levels of the organization
  • Demonstrated budgeting, forecasting, and fiscal management skills
  • Proven highly developed leadership skills with ability to supervise, mentor and objectively evaluate internal or external resources; resolve conflict, and collaborate effectively
  • Exert knowledge of FDA, ICH, and GCP guidelines

Outpatient Clinical Auditor Resume Examples & Samples

  • Certified Medical Coder with at least one of the following credentials: CCA, CPC, CCS, RHIA, RHIT
  • 3+ years prior coding experience
  • Experience in prospective payment methodologies
  • Knowledge and experience in health care environment/managed care
  • Strong knowledge of Microsoft Office products (Word, Excel)
  • 3M Coder/EncoderPro experience

APC Clinical Auditor Resume Examples & Samples

  • Ability to work independently and manage work load
  • Strong knowledge of Microsoft Access
  • Strong knowledge of ICD-9 coding
  • Proficiency in Microsoft Office applications, including Word and Excel
  • Previous call center or customer service experience
  • Must be available to work any shift as required to meet business needs
  • Previous experience in the healthcare field

Market Clinical Strategies Process Analyst Resume Examples & Samples

  • Bachelor's Degree in business related field or equivalent work experience
  • High level proficiency with Microsoft Office applications (Word, Excel, Power Point)
  • Strong background data analysis and analyzing large sets of data
  • Experience in completing efficient analysis of data with associated conclusions and recommendations for improvement
  • Strong organizational and effective time management skills
  • Ability to work cross-functionally to achieve results
  • Previous health insurance industry experience
  • Previous experience with Process Improvement methodologies
  • Bilingual – Must be able to speak, read, and write fluently in both English and Spanish
  • Masters in School Psychology or Bachelors in Speech-Language Pathology
  • Must have demonstrable expertise, training, and clinical experience in the area of psychological and/or speech-language assessment, as well as interest in applying aforementioned expertise, experience, and skills to the development of published print and digital clinical assessments
  • Must have strong oral and written communication skills in Spanish and English, good planning and organizational skills, interest and training and/or basic graduate level skills in research methods and statistics, ability to work as part of a team, flexibility, and desire to learn the test development and publishing process
  • Subject Matter Expertise: Expertise in assessment in the area of psychology or speech-language disorders, training and/or experience in research, and practical experience in both psychological/speech-language testing and intervention
  • One or more of the following skills are highly desirable
  • 2 years of Quality Assurance (QA) or Compliance experience
  • Strong analytical, organizational and time management skills
  • Comprehensive knowledge of Microsoft Word and Excel
  • Team Player, ability to work within stringent deadlines, multiple priorities, as well as work independently
  • Excellent interpersonal, written, and verbal communication skills
  • Bachelor’s or Associate’s Degree
  • Previous Medicare, commercial, and legislative/regulatory experience
  • Knowledge of Access
  • Knowledge of CMS guidelines
  • Quality audit background desired
  • Experience in project management
  • Bilingual (English and Spanish), preferred; must be able to read, write and speak English

Clinical Audit Data Consultant Resume Examples & Samples

  • Proficiency in advanced functions of Microsoft Excel and PowerPoint, Visual Basic and macros
  • Ability to gather data from multiple sources and compile it into a user-friendly format and present data, concepts, processes, and ideas to teams and leadership
  • Demonstrated skill in development of recommendations and implementation of solutions based on financial and other project data
  • Ability to develop new reporting based on an in-depth understanding of different types of reporting needs
  • Ability to absorb and retain information readily, prioritize tasks to meet fluctuating demands, and work under deadline constraints
  • Proven experience leading and supporting projects
  • Bachelor’s degree in Math, Economics, Statistics, Computer Science, or relevant industry experience
  • Intermediate knowledge of Microsoft Access, PLSQL, SAS, or TOAD
  • Ability to utilize analytical thinking in determining root cause from result data
  • Gifted in creative thinking and root cause analysis
  • Experience in the health insurance industry
  • Bachelor’s Degree in Business or Healthcare field
  • Excellent PC skills required. Specific expertise with MS Word, Excel and Sharepoint required
  • Excellent communication skills - written and verbal
  • Previous budget and/or financial reporting experience
  • Previous data analytics experience

Clinical Disputes Analyst Resume Examples & Samples

  • Excellent communicate skills, both written and verbal
  • Ability to collaborate with multiple teams at various levels
  • Strong organizational/problem solving skills with ability to handle multiple priorities
  • Working knowledge of Excel and Access
  • Clinical experience/knowledge

R&D Clinical Trials Finance K-k-kb Resume Examples & Samples

  • Work with the senior management team to create long range financial and strategic plans
  • Drive strategic planning and work closely with other business groups to develop alternatives and strategies
  • Manage all inputs from cross-functional groups to the P&L models
  • Develop cost estimates for product development and research activities such as preclinical and clinical studies activities/accruals
  • Manage timeline and total project deliverables (develop presentations for senior finance management, final deck and model output summaries, etc)
  • Ability to handle multiple tasks with attention to detail
  • Strong collaboration, organizational, and problem-solving skills
  • Possess self-drive and strong initiative
  • At least 2 years’ experience with claim payments/processing
  • Microsoft Access
  • Associates or Bachelor’s Degree of Art or Science
  • Sharepoint Site Owner and/or Designer Training completed

Frontline Lead Non-clinical Team-intermountain Region Resume Examples & Samples

  • Report trends
  • Develop system-view recommendations
  • Implement appropriate actions to control trend
  • Create and conducts provider outreach initiatives
  • Ensure compliance with regulatory requirements
  • Recommend alternatives if appropriate using your knowledge of clinical protocols
  • Identify members for specific case management and / or disease management activities
  • Monitor multiple departmental activities, coordinating functions across utilization management and case management teams that drive positive outcomes for Humana members, Humana providers, and to Humana
  • Clinical experience in an acute care, skilled or rehabilitation clinical setting
  • May substitute equivalent education and/or experience for degree

Temporary Clinical Handscorer, Wisc Spanish Resume Examples & Samples

  • Apply judgment to score subjective data. Specifically, score brief verbal responses to questions that involve critical thinking, reasoning, recall of information, or providing definitions of words
  • Score subtests that require visual discrimination (e.g., evaluate marks that indicate examinee’s response to visually presented problems)
  • Score subtests that require objective data entry
  • Must be proficient in written and spoken Spanish and English
  • Critical thinking skills to apply basic scoring rules
  • Ability to perform independently without consulting others (i.e., willing to perform quiet work without discussing scoring decisions with co-workers)
  • Available to work at least 7.5 hours per day, Monday through Friday
  • Accept and respond to supervision from the Development Team, Team Leaders, and/or Scoring Supervisor
  • Flexible and willing to perform other clerical duties as needed (e.g., photocopying and filing)
  • Masters in School Psychology or Bachelors in Speech-Language Pathology (or related field)
  • Must have demonstrable expertise, training, and clinical experience in the area of psychological and/or speech-language assessment (or a related field), as well as interest in applying aforementioned expertise, experience, and skills to the development of published print and digital clinical assessments
  • Clinical/educational/research experience involving administration and interpretation, and/or development of clinical assessment instruments
  • Bilingual: ability to speak, read, and write fluently in both English and Spanish is preferred, but not required

Clinical Intelligence & Analytics Actuarial Analyst Resume Examples & Samples

  • Perform root-cause analyses to support leaders in answering the “why’s”
  • Meets requirements for Humana’s Actuarial Professional Development Program (APDP)
  • Prior experience with data analysis and reporting

Clinical Formulary Management Process Manager Resume Examples & Samples

  • Serves as the Clinical Formulary Process Manager overseeing the Medicare and Medicaid lines of business
  • Leads the development, maintenance and improvement of formulary processes. Ensures processes, policies and procedures are efficient and compliant with Medicare-CMS requirements
  • Manages the creation of new formularies and maintenance of existing formularies and drug lists in Humana’s formulary management system
  • Ensures accuracy and compliance of formularies and associated formulary data with Medicare-CMS regulations
  • Manages associates and grows staff talent
  • Prior formulary management and/or pharmacy claims processing systems experience
  • Expertise in Medicare-CMS regulations
  • Excellent data analysis and experience working with Access, SQL and Excel
  • Highly proficient with MS Word and Visio
  • Experience in a health services or technical field

Clinical Authorization Rep-pre-arrival Resume Examples & Samples

  • 2 years of experience in a hospital, medical office/doctor’s office or working for a health insurer required
  • Oncology experience is preferred
  • Knowledge of the health insurance industry and claims processing a plus

Clinical Consulting Practice Resume Examples & Samples

  • Apply internal processes and enforce project standards
  • Review expectations/deliverables prepared by senior leadership/ business owner
  • Coordinate deliverables with business owner
  • Coordinate project plan and drive towards deliverables
  • Develop clear and concise documentation
  • Provide strong organization and effective communication skills (oral and written)
  • Facilitate regular status meetings with business owner/project teams/steering committees
  • Manage task/action item priorities
  • Report progress of project deliverables and milestones
  • Manage timely decisions to support project
  • Proficiency in communicating effectively with project stakeholders up to and including leadership
  • Obtain additional knowledge by asking questions, exploring different options, being creative and thorough, and open to new ideas
  • Regular use of Microsoft PowerPoint, Word, Excel, Project, Outlook, SharePoint and Visio
  • Have knowledge of and ensure completion of departmental intake forms when applicable
  • Adoption of Process Discipline philosophy and utilization of project management related support material
  • Project Standards: (Charter, RACI Model/Roles and Responsibilities, Governance Structure, Project Plan, Risk/Issues Tracking)
  • Bachelor’s Degree in business or related field or 10 years equivalent work experience
  • Ability to manage stakeholders and hold them accountable for deliverables
  • Ability to facilitate meetings with multiple participants capturing all relevant information
  • Ability to execute tasks captured in a project plan
  • Ability to manage deliverables from third party vendors
  • Project Management Institute certification - PMP
  • Prior experience in a clinical setting
  • Previous experience planning and managing large projects
  • Prior experience in the health solutions industry
  • Support various U.S. and international teams with the ingestion of test content onto digital platforms
  • Participate in user acceptance testing of digital and print materials to ensure all content and scoring requirements are met prior to market release
  • Train and support team members on use of digital tools for the creation, entry, and quality assurance of test content
  • Train and support Field Research Examiners on the use of digital tools for test administration
  • Document and provide detailed description of technical defects, and work with engineers and other development staff to resolve them
  • Develop item art specifications and work with the Design, UX, and Production teams to ensure that visual and verbal item stimuli meet both print and software specifications and usability standards
  • Participate in developing and refining test items and working with the Research Director, UX, Engineers and others on test content and format
  • Work with project teams to ensure that all test kit materials and deliverables, both in print and digital mediums, are prepared in a timely manner to meet the publication schedule
  • Manage scorers hired to score the verbal responses received on tests in development
  • Work with RDs and CADs from each team to determine future scoring needs, as well as the budget for those scoring needs
  • Work with Human Resources to hire individuals to score the verbal responses received on test research protocols
  • Work with department Administrator to obtain workstations and computers for scorers to do their work
  • Monitor the work of the scorers to ensure accuracy and reliability of scoring
  • Determine if scorers are meeting expectations, provide corrective feedback if they are not, and monitor progress towards goals
  • Work with other CADs to ensure scorers receive proper training and retraining as needed
  • Masters in Psychology, Experimental Psychology, School Psychology, or a Bachelors in Speech-Language Pathology. Related field acceptable
  • Must have strong oral and written communication skills, good planning and organizational skills, interest and training and/or basic skills in research methods and statistics, ability to work as part of a team, flexibility, and desire to learn the test development and publishing process
  • Good skills using basic computer software programs (e.g., Word, Excel) and the ability to use or learn digital communication tools such as video conferencing
  • Demonstrable expertise, training, and clinical experience in the area of psychological and/or speech-language assessment, as well as interest in applying aforementioned expertise, experience, and skills to the development of published print and digital clinical assessments
  • Digital Aptitude: Familiar with many coding languages and interested in learning new ones. Knowledge of HTML, XML, SAS, JSON
  • Proficiency with Adobe Creative Suite and the ability to create design specifications or test mock-ups
  • Familiarity with UX design principles and User-centered design
  • Experience creating an app or prototype (Axure, Bootstrap, HTML, CSS, JavaScript, etc.)

Clinical Innovations Data Analyst Resume Examples & Samples

  • Identify and document data quality issues and data capture gaps in order to identify analytical opportunities
  • Prior experience creating and delivering executive level presentations
  • Bachelor in Business, Math, Statistics, Public Health, Finance or other health related field preferred
  • Experience in managed care or health care administration preferred

Clinical Handscorer Resume Examples & Samples

  • Enter data from subtests into Scoring Assistant software
  • Organize, and electronically file protocols
  • English is the applicant’s first language. Proficient in written and spoken English

Clerical Specialist, Clinical Team Resume Examples & Samples

  • Professional experience in healthcare
  • Ability to multitask in a professional manner
  • Proficient in MS Office applications and a demonstrated technical aptitude to quickly learn new systems
  • Associate’s advanced degree

Clinical Messaging Consultant Resume Examples & Samples

  • Lead and drive the execution of Proactive Care Strategy initiatives, programs and projects associated with messaging and interventions
  • Develop interventions, programs and messaging for members in all lines of business
  • In partnership with various internal and external partners, the Clinical Messaging Consultant will evaluate operational feasibility, define operational strategies, develop implementation plans, oversee day to day performance monitoring and operations, and project evaluation completion
  • Manage strategic partnerships to drive successful roll-out of proactive strategy initiatives and define in flight modification and identify key insights for future strategy development
  • This position will provide oversight of flawless execution of initiatives and the management of performance, risks and issues for the following key areas: (1) Quality and Stars maximization, Clinical Trend and Pharmacy programs and services (2) Program engagement activities for targeting members for self-care programs for those newly diagnosed or those with low acuity chronic diseases, and (3) Complex multi-channel outreach programs to members and providers to close gaps in care, address non-compliance, and educate about chronic disease
  • Bachelors Degree in Nursing, communications, health education/promotion or any field
  • Process experience and/or Project Management experience
  • Experience working with vendors to deliver solutions that meet business objectives
  • Ability to manage/oversee multiple projects with cross-functional stakeholders
  • Excellent PC skills (including MS Word and Excel)
  • Experience working external vendors
  • Knowledge of healthcare and/or clinical concepts and conditions

Clinical Handscorer Celf-temporary Resume Examples & Samples

  • Score subtest that require objective data entry
  • Transport, organize, and file protocols
  • Photocopy, type, and perform miscellaneous clerical tasks
  • Available to work required schedule within Monday - Friday
  • Must anticipate reliable daily attendance with punctuality (e.g., arrive on time, leave and return from scheduled breaks/ lunch at appropriate times)
  • Accept and respond to supervision from Development Team, Team Leaders, and/or Scoring Supervisor
  • Be able to recognize questionable or problematic protocols that require attention from supervisors (e.g., cases with missing or unusual data, numerous cases with questionable data from the same examiner)
  • Experience Preferred: Prior experience scoring psychological tests

Clinical Optimization Technology Consultant Resume Examples & Samples

  • Derive observations and insights from metrics to support and improve clinical operations
  • Conduct independent research necessary to fully understand and correctly utilize the required clinical data
  • Continually identify ways to improve and enhance current reports, increasing value and usability
  • Highly proficient with reporting and query tools including MS Office (Access (develop/create queries) and Excel (building pivot tables, create tables, charts, graphs))
  • SQL, ability to build code to query database
  • Assist business leaders in understanding the “story” contained within or behind the data/report
  • Assist others on how to more efficiently code
  • Ability to build summary tables
  • SAS, ability to code queries
  • Strong mathematic and/or statistical skills
  • Flexibility to work between 7 a.m & 7 p.m EST and occasional weekends, as needed
  • Previous healthcare/customer service experience in a clinical setting
  • Ability to communicate and collaborate with internal/external physicians, nurses and support staff through multiple mediums

Clinical Finance Consultant Resume Examples & Samples

  • Manage departmental activities to ensure accurate and timely financial and statistical reports and data are delivered
  • Develop methods and criteria for measuring and summarizing financial data and preparing complex analyses
  • Ensure departmental adherence to corporate guidelines, performance standards and all applicable laws and regulations
  • Strong financial reporting skills (expenses, profit)
  • Knowledge of Hyperion Smart View
  • Strong Excel proficiency (as defined by creating complex formulas within a cell, pivot tables, v-look ups, etc.)

Clinical Formulary Management Resume Examples & Samples

  • Bachelor of Science in Pharmacy or PharmD Degree
  • Active pharmacist license in the state(s) in which you are required to practice
  • 3 years clinical experience in managed care
  • Previous experience with pharmacy benefits management
  • Previous Medicare and/or Medicaid experience
  • Strong organizational skills and ability to stay on schedule
  • Proven problem-solving and troubleshooting skills
  • Ability to work independently and within a team setting to achieve goals and meet deadlines
  • Excellent verbal and written presentation skills with ability to communicate effectively across all levels of the organization
  • Ability to take initiative, multi-task, and work in a fast-paced environment
  • Comprehensive knowledge of Microsoft Office applications, including Word, PowerPoint & Excel
  • Ability to manage end-to-end-processes
  • Understand Humana’s business processes, systems, tools, regulations and structure and how they interrelate to provide products and services that create value for Humana members
  • Previous management experience and ability to lead teams
  • Previous program or project management experience
  • Proven success in leading teams (both direct and indirect) with multiple accountabilities
  • Lean, 6 sigma experience and/or certification

Clinical Finance Analyst Resume Examples & Samples

  • Maintain the general ledger to include preparation of journal entries, account analysis and reconciliation, supports the month end close process
  • Prepare and present financial data to management for review and decision making
  • Research and analyze financial information necessary to support internal and external audit activity
  • Bachelor’s Degree in Finance, Accounting, Business or related field
  • Highly proficient with MS Office (Access and Excel)
  • Team player with strong interpersonal relationship, team building, collaboration and facilitation skills
  • Must have ability to work closely within a small team or independently
  • Experience assimilating data and information to make prompt decisions and share results with colleagues
  • Must possess strong data analysis skills
  • Strong problem solving and troubleshooting skills, especially around data acquisition and delivery
  • Ability to effectively communicate with co-workers, other departments, and leadership through written and verbal communication in the highest professional manner
  • 2-3 years or more of professional work experience
  • ESSBASE experience

Clinical Assessment Test Data Entry Resume Examples & Samples

  • Assist various departments in typing correspondence and legal documents
  • Perform database work and data entry
  • Responsible for other administrative tasks such as filing, scanning, copying/binding
  • Edit and proof documents as necessary

Clinical Handscorer Wisc-v Spanish Resume Examples & Samples

  • Apply judgment to score subjective data. Specifically, score brief verbal responses to
  • Receive and respond to training in the aforementioned responsibilities
  • Spanish is the applicant’s first language. Proficient in written and spoken Spanish
  • Sufficient computer skills to perform data entry (e.g., basic word processing, web browsing, Excel)
  • Achievement of a scoring accuracy rate of at least 90% after training and maintenance of that level throughout the scoring assignment
  • Ability to perform independently without consulting others (i.e., willing to perform

Clinical Sciences Leader Shanghai Resume Examples & Samples

  • Multi-tasking - Capacity to manage several activities in parallel with respect to established schedules
  • Good communication skills (verbal, written and presentation skills)
  • Managerial skills
  • Provides clinical operational leadership for build, maintenance, submissions and updates of formularies and drug lists
  • Ensures accuracy of formularies and utilization management (UM) criteria in the Centralized Formulary System
  • Evaluates new medications and accurately incorporates them into Humana’s formularies if appropriate
  • Researches and resolves member benefit inquires
  • Understanding of UM criteria for step therapy, prior authorization, and dispensing limits
  • Partners with other functions to operationalize formularies and related products
  • Actively participants in Pharmacy and Therapeutics Committee and Drug Utilization Review team meetings
  • Collaborates with other pharmacists and healthcare professionals in a team environment
  • Manages and communicates line of business priorities
  • Performs formulary analysis and reporting
  • Provides excellent service to our customers and key stakeholders
  • Develops and leads metrics discussions to deliver process improvements and business results

Senior Director of Clinical Engineering Resume Examples & Samples

  • Hires, places and develops management and supervisory staff within the CE department, while maintaining a strong focus on retention and team development
  • Maintains an active succession plan for key roles within the system
  • Oversees implementation of human resources polices and procedures, including regular performance reviews and effective performance management, in a corporately responsible manner
  • May manage multiple-site systems and multiple client relationships
  • Establishes productive business relationships within the C-suite
  • Schedules and documents communication with client on a monthly basis, to include Quarterly Joint Reviews and Annual Performance Reviews, that focuses on marketing the accomplishments of Aramark
  • Makes sound decisions, independently, to drive service delivery outcomes to the satisfaction of key client stakeholders throughout the hospital
  • Maintains departmental policy and procedure manuals ensuring 100% compliance with Aramark Healthcare Technologies standards
  • Seeks out new business opportunities for Aramark within account
  • Master’s degree in biomedical equipment technology, electronics, or engineering preferred
  • Minimum of 10 years experience in related field, with at least 8 years of supervisory experience

Cerner Clinical Strategist Resume Examples & Samples

  • Bachelor's degree in Nursing or in a related field
  • 5 years of experience as a Registered Nurse
  • Current active Registered Nurse license
  • Have not been censured or forced to relinquish license due to impropriety
  • Ability to travel up to 100%
  • Inpatient (acute and critical care) nursing experience
  • Four years of healthcare management experience

Clinical Interaction Specialist Resume Examples & Samples

  • Conducts calls with patients, reviews the case file and completes a medical interview to obtain the required information as designated by the TeleMed interview system
  • Uses a consultative approach supported by medical knowledge and defined policies and procedures to uncover and collect information regarding conditions, treatment, medication usage, recovery etc
  • The CIS has a focus on providing an excellent customer service experience to all patients, acting as an advocate for them by providing information about preventative care available through their insurance carrier
  • Acts as a courteous, professional medical representative and customer advocate to obtain necessary information, document collected information efficiently and credibly to ensure a complete and accurate medical interview is completed and filed with the insurance carrier. Demonstrates empathy and compassion when needed
  • Responsible for following defined policies, procedures and standards for professional conduct, the CIS must perform within Quality standards to ensure consistent, accurate, professional patient interactions
  • Acts in compliance with all HIPAA guidelines and standards of care in patient interactions. Uses good judgment, tact and compassion to handle the delicacy of exchanging personal health information and the nature of sensitive medical information
  • Maintains a consistent knowledge of all Client programs which he/she has been trained on. Willingly accepts additional training to expand skills to become capable of servicing a higher number of patients across varying client programs
  • Accepts responsibility for actions and executes transactions with the knowledge that every interview is confidential and information obtained requires extreme accuracy as the information collected generates legal documents which are filed with the insurance carrier
  • HS Diploma/GED is required
  • Must have completed a degree in an approved accredited program as a Medical Doctor (MD), Registered Nurse or Licensed Practical Nurse
  • Must have strong customer service skills
  • Medical Terminology is required
  • Typing 25 wpm
  • Proficient with computer/internet research skills
  • Strong oral communication skills
  • MUST BE ABLE TO WORK MONDAY - FRIDAY 12:30 - 9 P.M

Clinical Excellence Practice Leader Resume Examples & Samples

  • Bachelor's degree or equivalent experience required plus 10 years of relevant experience in the clinical consulting field plus software application experience in the healthcare industry
  • Experience in health care quality management, administrative case management, public health administration or other research based outcomes evaluation necessary.&#8217
  • Ability to regularly interact with senior management or executives on matters concerning several functional areas, divisions and/or customers
  • Requires the ability to change the thinking of, or gain acceptance from others in sensitive situations, without, while maintaining productive relationships
  • 10 years experience in growing and developing professional teams to deliver new offerings
  • Knowledge of healthcare software
  • Knowledge of software development process
  • Knowledge of product integrity matrixes
  • Time management and Organizational skills
  • Ability to communicate effectively, both verbally and written, with customers, co-workers and business contacts in a courteous and professional manner
  • Strong analytical ability
  • Ability to establish effective, professional working relationships with clients and co-workers
  • Experience in Six Sigma

Clinical Site Director Resume Examples & Samples

  • Active New York State Registered Nurse license
  • Background in any surgical specialty

Clinical Guidance Specialist / Vsp-san Juan Resume Examples & Samples

  • Associate’s or Bachelor’s Degree in clinical related field
  • Familiarity with medical terminology and/or ICD-10 codes, CPT’s , HCPCs
  • Bilingual English/Spanish
  • 3+ years of experience in a managed care organization or acute inpatient hospital experience in chronic or complex care
  • Strong computer and typing skills
  • 2+ years' experience in utilization review with strong cost containment/case management

Manager, Market Clinical Strategies Analytics Resume Examples & Samples

  • Lead a team of associates to develop and produce reporting packages the support HSO operations and Medicare clinical programs
  • Maintain and enhance current Medicare clinical operations dashboards for tracking and reporting of key business indicators
  • Support rollout of new system functionality, including responsibility for operational readiness validation, post production validation and triage of issues encountered
  • Further the Market Clinical Strategies vision for continuous improvement by assisting in identifying best practices in Humana’s Medicare Regions and formulating proposed solutions to address identified barriers
  • Develop team members to meet the goals of the organization (Enhancement tracking, Training and Communication, Issue tracking and resolution)
  • Bachelor’s degree in Business, Information Technology or related field
  • Minimum two years of recent experience with SQL reporting (SQL Server Enterprise Manager, SQL Server Management Studio, etc)
  • Proven experience utilizing technology to facilitate data automation/report creation
  • Proven experience with very large data sets
  • High-Level proficiency with Microsoft Office suite (Advanced Excel and Access proficiency)
  • Excellent organizational and multi-tasking skills required
  • Previous experience with Medicare line of business
  • 1 year outpatient auditing experience
  • Strong knowledge of CPT/HCPS coding
  • Proven proficiency for APC and observation coding

Clinical Applications Leader Resume Examples & Samples

  • Contribute to the definition, design and refinement of software products and services to address customer needs
  • Establish and maintain close contacts and collaboration with external Key Opinion Leaders and researchers (directly and through sales organization) to build a network of high profile customers by developing advanced applications with them and create or sustain Reference sites, establish credibility and drive clinical strategy
  • Participate in Medical Advisory Board meetings to build application roadmap and provide input to Product Marketing
  • Assist with the reporting of data at scientific congresses, customer seminars and internal training events
  • Support the development, maintenance, improvement & implementation of working routines/standards for experimental procedures, reporting of consultancy projects, contracts with customers
  • Identify opportunities to use the results of process development projects in sales situations or marketing material. Facilitate and support the transfer of this information into the corresponding marketing and product management teams
  • Responsible for the clinical evaluation of new software, options, and systems prior to release
  • Establishes link between Global Clinical Insights and local Sales and Applications team
  • Bachelor’s degree in a relevant scientific or clinical area, or current Sonography credential(s) and/or Medical degree
  • Highly qualified in multiple clinical ultrasound applications
  • Experience working with Customers
  • Experience in communicating scientific data (lectures, posters, papers)
  • Ability and willingness to travel, including international travel

Clinical Marketing & Applications Specialist Resume Examples & Samples

  • Monitor customer
  • Communicate
  • Required active professional clinical/technical certifications/registries necessary to perform ultrasound scanning on live patients in a clinical environment (General Imaging)
  • Willingness to travel extensively within your specified geographic region as well as to occasional nationwide or international sites. Representation in meetings and tradeshows may additionally be required
  • Experience in communicating scientific data (talks, posters, papers)
  • Innovation – develop new ideas through collaboration and execute on creative ideas
  • Teaching ability: present complex material/ techniques in comprehensible terms
  • Fluency in English (spoken and written)

Clinical Trial Materials Manager Resume Examples & Samples

  • Responsible for developing strategies for investigational product packaging design in support of early and late stage development clinical studies conducted by client
  • Serve as liaison with Clinical Operations for investigational medicinal product (IMP) supply needs and timelines, including clinical supply forecasting, supply strategy development and implementation
  • Coordinate and oversee IMP packaging and labeling activities at contract manufacturers, including review and approval of packaging and labeling documentation and batch records
  • Utilize project management and interpersonal skills to deliver packaging products to deadlines and within budget
  • Generate and review packaging, labeling and storage sections of relevant clinical and regulatory documents; ensure cGMP compliance in packaging, labeling and distribution activities
  • Manage shipment and storage of bulk drug product and finished drug product for development phase programs; track the import and customs clearance of supplies being shipped to study sites and depots
  • Coordinate return and destruction of clinical supplies from study sites

Clinical Intelligence & Analytics Metrician Resume Examples & Samples

  • Bachelor’s Degree in Math, Engineering or a related field
  • Experience using Structured Query Language, SAS and/or SPSS
  • Graduate Degree in Applied Sciences or Statistics
  • Actuarial background, preferably near Actuarial Sciences Associate level
  • Experience with large data sets and/or the analysis of patient-level healthcare
  • Knowledge of Oracle

Clinical Application Engineer Resume Examples & Samples

  • Design input for the requirements of customers in respect of C-Arm product work flow, user interface, operational usability, good practice …… to translate all of these requirements into interaction design concepts
  • Responsible for the external evaluation or clinical trial of the newly developed products. It includes the clinical site choice, agreement with the hospital as evaluation site, clinical support during all process of the evaluation, collection of the clinical data and drafting the clinical evaluation report eventually
  • Enhance the clinical experience within engineering team. Contact hospital to organize engineers to participate in clinical observations in real surgery operation, manage the expertise to give clinical class training for all develop engineers
  • Clinical validation for the newly developed products. Verify all workflows of the newly developed product, posing as an end-user. It includes drafting the validation procedure/plan, conducting the validation, evaluating the acceptance of the product from an end user viewpoint, and give the finally validation report as program required
  • Risk assessment to the product quality complaint in respect of clinical applications, to find the potential hazardous situation from the user-using standpoint and give the mitigation proposal
  • IB support, to give customer high quality clinical operation training to enable them to use the new product better. And help them to have some trouble shooting ability related with product operation
  • Create or innovate new application concept, which could be highly accepted by customers and bring much benefit once integrated into product

Clinical Trial Management Resume Examples & Samples

  • A minimum of a Bachelor’s degree or equivalent University degree is required
  • Minimum of 8 years clinical trial management experience in the pharmaceutical industry or CRO is required, however, other relevant experiences and skills may be considered
  • Clinical research operational knowledge is required
  • Prior global clinical experience is required
  • Knowledge and familiarity of ICH Guidelines; familiar with FDA regulations and the EU Clinical Trial Directive and other applicable GxP regulations
  • Thorough understanding of current Clinical R&D processes, practices and systems
  • Experience or ability to work cross-functionally and in a matrix environment, with ability to liaise with key customers is required
  • Excellent Presentation and facilitation skills is required
  • Able to transfer knowledge to others in team or department applying knowledge of how to deliver training sessions for maximum impact and retention is required
  • Able to independently plan, organize, co-ordinate, manage and execute assigned tasks is required
  • Strong networking and relationship building skills
  • Ability to create an open and inviting environment
  • Ability to Embrace generational differences
  • Exceptional written and verbal communications skills
  • Proven coaching skills
  • Proficiency in English language (both oral and written) is required.Clinical Trial Coordination

Clinical Franchise Leader Vaccines Resume Examples & Samples

  • Company SOP/WI relevant to the job
  • Minimum 5-10 years industry experience in drug/vaccine development

Clinical Product Analyst Resume Examples & Samples

  • Acts as the Product Owner within an Agile scrum team performing the following
  • Troubleshoots in support of issues that come up from Services Team
  • Provides training on the product to other groups and may support training efforts with Customers
  • Works closely with Product Management to understand the strategic roadmap and provides input
  • Keeps current with industry trends and domain expertise
  • Establish a commitment to quality and communicate the importance of meeting statutory, regulatory and customer requirements. Ensure quality policy is understood, implemented and maintained at all levels of the organization. Establish and communicate quality objectives that are measurable and consistent with the quality policy
  • Maintain adequate organizational structures and adequate resources of sufficiently trained personnel. Ensure qualified personnel relative to assigned responsibilities. Ensure appropriate responsibility, independence and authority of all personnel who manage, perform and assess work affecting quality
  • Bachelor’s Degree in Product Management, Marketing, Engineering, Business Administration, healthcare or related field
  • 5+ years’ experience in product management, product development, or related field
  • Clinical background is a MUST
  • MBA or MBBS, BDS or equivalent degree related
  • 5+ years’ experience in product management, product development or related field
  • Healthcare product/industry/technical acumen
  • Demonstrates ability to problem solve
  • Proven ability to influence and negotiate internally and with customers

Clinical Trial Financial Analyst Resume Examples & Samples

  • Invoice industry sponsors in a timely manner to ensure payment
  • Reconcile and monitor of clinical trial expenditures and payments
  • Review research expenditures to ensure accuracy and appropriateness prior to billing sponsor
  • Prepare monthly reports using SAP accounting software, BRAIN, QuickBooks, Clinical Trial Management System (CTMS) and/or contract tracking data
  • Maintain budget section in clinical trial management system
  • Track all revenue and expenditures related to studies in QuickBooks/CTMS
  • Maintain Investigator efforts and communicate effort with Investigator
  • Interact with outside affiliates to obtain pricing related to research costs
  • Analyze and manage clinical trial budgeting, billing and revenue processes
  • Manage the process of opening, closing and maintaining clinical trial accounts in related financial systems
  • Assist with creation and reconciliation of internal/external billing policy ensuring compliance with applicable federal regulations
  • Develop and maintain SOPs and procedural guides
  • Maintain data of all active, pending, and closed RRO clinical trials
  • Prepare detailed cost assessments for industry sponsored clinical trials and investigator-initiated studies
  • Serve as an information resource related to contracts for faculty, fellows, and staff. Maintain calendar for quarterly meetings with investigators
  • Ability to understand and manage the complexities of research contracts including issues related to informed consent, access to data, and conflict of interest
  • Excellent interpersonal skills, including the ability to work with faculty members, co-workers, support staff throughout the institution, and pharmaceutical company representatives
  • Direct experience in the financial planning of clinical trials strongly preferred
  • Strong attention to detail and data quality
  • Independent self-starter and leader, with a strong sense of ownership of driving for results

Clinical Trials Specialist Resume Examples & Samples

  • Identify potential problems and/or inconsistencies and inform supervisors as needed
  • Prepare a variety of reports, documents and correspondence for regulatory agencies, participating clinical trials sites and internal purposes to assist in the ongoing monitoring and evaluation of the clinical trial's progress
  • Recommend modifications to existing procedures and techniques to meet the needs of the particular clinical trials research study
  • Ensure distribution and maintain inventory of appropriate forms, supplies, equipment, laboratory samples and drugs required for execution of research protocol(s)

Adjunct Clinical Supervisors Resume Examples & Samples

  • Ph.D. or Psy.D. in clinical psychology from an APA-accredited program
  • Completion of an APA-accredited predoctoral internship
  • Licensed as a psychologist in the commonwealth of Virginia
  • Prior experience in clinical supervision; and
  • Prior experience with evidence-based interventions

Clinical & Advanced Course Manager Resume Examples & Samples

  • Overseeing the administrative operations of courses, including creation and management of complex schedules; reservation and preparation of classroom and clinical space for course sessions; and creation of faculty and student assignments
  • Implementing innovative educational technology solutions with an ability to acquire proficiency in emerging applications
  • Addressing educational technology requests from faculty and directing them to the appropriate resources in OCS and/or IT
  • Collaborating with clinical site administrators and coordinators
  • Planning and implementing clinical exercises, including those with patients
  • Tracking and providing faculty teaching effort data to inform the teaching compensation process
  • Delivering online curriculum materials in a newly adopted learning management system,
  • Organizing and actively participating in course and clerkship meetings, including setting agendas, presenting logistical and policy updates and action item follow up
  • Implementing the course and faculty evaluation process, and managing student assignment distribution/submission
  • Providing statistical and informational course data as required
  • Actively participating in, and providing ongoing senior staff support to, curriculum redesign and continuous improvement initiatives
  • Delegates tasks to and provides performance feedback for Clinical Courses Staff Assistant

Clinical Instructional Fellow Resume Examples & Samples

  • A short statement (no more than 1000 words) describing relevant experience
  • Writing sample (10 – 15 pages preferred)
  • List of at least three references; and
  • Law school transcript

Clinical Reseach Specialist Resume Examples & Samples

  • Participate in the evaluation of the protocol, study design and risk to subject population. Access and extract information for protocol development from medical library and online databases. Participate in protocol development or review of risk assessment for investigator-initiated trials. Assist in determination of staff availability and assessment of study population/availability. Participate in the preparation and negotiation of study budget. Determine facility/equipment availability. Participate in critical evaluation and make comment on contracts/agreement. Compose and supervise preparation of regulatory documents including updates to Informed Consent forms
  • Schedule study-related meetings and training sessions. Schedule and/or coordinate pre-study visit of sponsor/s
  • Identify potential subjects from review of existing protected health information based on Inclusion/Exclusion criteria. Recruit subjects according to IRB/protocol approved methodologies. Consent subjects including discussion of treatment and intervention alternatives and ensure that Informed Consent forms are properly signed before the start of the study. Determine appointments per protocol. Schedule and/or call subjects for appointments. Coordinate subject visits with support services
  • Will conduct study related assessments; provide or create source documentation tools; maintain files of drugs and oversee the proper handling of lab specimens

Clinical Laboratory Specialist Resume Examples & Samples

  • Position maintains both research and clinical diagnostic test environment
  • Performs a variety of technical procedures, including but not limited to: bloods, bone marrow, fresh, frozen, plastic, or paraffin specimens in the assigned laboratory
  • Maintains divisional compliance with all regulatory standards and adheres to all established QA/QC procedures. Documents results under quality assurance guidelines and provides recommendations to technical staff
  • Following standard operating procedures for preparing samples developed for molecular assays in support of patient care and research
  • Troubleshoots implementation of new venues or protocols to the lab SOP's. Develops new quality standards for molecular assays
  • Works closely with Laboratory Manager and Medical Directors to understand their scientific questions/aims, and offer support, implementation, and analysis of any type of molecular assay to reach their goals
  • Performs literature search and review, orders necessary supplies; in preparation for development
  • Ensures that data is accurately maintained and organized. Records timelines, status reports, and logs. Maintains laboratory notebooks
  • Works with laboratory support staff and assists in the training of technical personnel
  • Strict compliance with patient care and confidentiality policies. HTPAA regulations

Director of Clinical Finance Resume Examples & Samples

  • Clinical finance or academic medical center experience
  • Demonstrated knowledge of Stanford financial and decision support systems
  • User knowledge of Microsoft Office Suite
  • Advanced knowledge of Oracle or other business financial systems
  • Advanced understanding of financial principles
  • Ability to clearly and effectively present information to internal and external audiences, client groups and all levels of management
  • Strong analytical skills to review and analyze complex financial information
  • Strong leadership and management skills with previous experience managing people, delegating workload and providing direction/corrections as necessary
  • Knowledge of property management requirements related to Stanford or non-Stanford title of equipment and fabrications
  • Demonstrated competency in project management of a high volume of work, some of which is cyclical
  • If managing sponsored projects, ability to manage post and pre award administration for sponsored projects within his/her unit. Knowledge and fluency of governmental regulations and Cardinal Curriculum level I and II
  • Knowledge of procurement needs, including sole-sourcing, cost analyses, vendor requirements, and small business reporting
  • Experience working successfully with PIs, their administrative staff, the office of sponsored research and external sponsors
  • Demonstrated success in performing meticulous, high quality and compliant work
  • Ability to interpret complex research and fiscal policies, assimilate information from a wide range of resources and act like a mentor and resource to others

Clinical Trials Disclosure Manager Resume Examples & Samples

  • Biostatistics or scientific background preferred
  • Stanford University or Academic Medical Center knowledge preferred
  • Strong knowledge of NIH regulations, and ClinicalTrials.gov
  • Bachelor’s degree and five years of related experience including two years of supervisory experience or a combination of relevant education and experience
  • Experience in a lead role and interactions with federal agencies, i.e. FDA
  • Expert knowledge of regulatory affairs, including IRB review and approval process and Good Clinical Practice
  • Knowledge of International Conference on Harmonization (ICH) standards
  • Experience in developing and implementing multifaceted projects

Assoc Clinical Dept Admin Resume Examples & Samples

  • In conjunction with Chair and Administrator, analyzes opportunities to develop programs within the department
  • Develops and maintains weekly, monthly and annual reports to monitor activities and expenditures in the department
  • Directly supervises one Unit Manager and indirectly supervises the Unit Manager's subordinate staff; directly supervises surgery scheduling team and billing and coding team
  • Prepares/compiles/writes complex reports that summarize department's goals and accomplishments. Develops policies and procedures for administrative functions in the department
  • Assists the Medical Director in development and marketing plan for new services and referral sources
  • Acts as representative of the clinic at community events, professional meetings and conferences. Supervises clinic personnel who may be participating at these events
  • Serves as purchasing liaison for BA and PO related purposes; applicable towards agreements, and vendor set-ups
  • Assists with Inventory tracking within the clinic
  • Experience with reviewing and submitting contracts
  • Responsible for QC and review of study documentation for Trial Master File (TMF) quality for sponsor and/or CRO studies
  • Responsible for resolving queries of the QC1 and QC2 reviewers before they are escalated to the PM and senior document specialists
  • Be proactive in researching eTMF or available resources to find answers to the queries of QC1 and QC2 reviewers
  • Assist senior document specialists for conduction trainings for new joinees, re-training for team members as required on an ongoing basis
  • Assist study leads to ensure smooth functioning of assigned projects from start to end
  • Assist study leads for managing Q&As for assigned projects
  • Coordinate with PMs for requirements of updates in system configurations or mapping documents
  • Assist the PMs for client meetings or provide them required data on assigned projects as required by the clients
  • Review audit plans before finalizing with the client and ensure the internal audits are performed as per Audit plan
  • Perform random QC checks on assigned projects to ensure eTMF quality
  • Come up with valuable suggestions for improving the processes and performances of fellow team members
  • Be able to take up mentorship role for fellow team members as required
  • Coordinate with all the team members across the globe and ensure that all the teams function in a similar way across a project to ensure consistency
  • Work on cross functional teams including Project Management, Business Development Client Services, Development and IT on the implementation and management of client projects
  • Gather and provide feedback on features and enhancements that may be needed on an ongoing basis to development team
  • Serve as part as the Project team on client projects
  • Participate and become an expert in the TMF Reference Model and stay current on regulatory changes
  • Become an expert in Trial Interactive features and functionality and work with GM, Life Sciences Solutions, Project Management and Development to recommend new features and functionality to improve the product and reduce manual activities
  • Respond to client requests for new project initiatives. Collaborate with various members of the production and sales teams to assess the scope of work and produce cost estimates
  • Take a proactive role in learning about clients’ industry, business needs and company culture, educating the project team, identifying new business opportunities and providing a high level of service
  • Set and fulfill client expectations
  • Perform other special projects or duties when required
  • Minimum Bachelor’s Degree from a 4-year college or equivalent
  • Minimum of 4-6 years of experience in the life sciences industry
  • Previous employment in Pharmaceutical, CRO, Medical Device, Investigative Site or eTMF preferred
  • Experience with essential documents and other study documentation
  • Knowledge of clinical development phases and processes including GCP and ICH regulations
  • Experience in a leadership role preferred
  • Proficiency in Microsoft Office (Word, Excel, Outlook), and knowledge of eClinical technologies
  • Proficiency in Document Management, (Adobe professional, knowledge of Scanning, indexing, using of ISI Tools and Capture Perfect)
  • Must be able multitask in a fast-paced environment, work well with people from a variety of different backgrounds and cultures, build relationships with clients and co-workers, work independently and as part of a team, take active measures to solve problems and commit to a high level of service

Clinical Document Scanner Resume Examples & Samples

  • Proof of high school diploma or GED required
  • File and/or scan/uploading experience
  • 1 - year clinical or medical records experience
  • Prior office or clerical experience
  • Able to multitask in a fast-paced environment
  • Prior experience in the Life Sciences industry (pharmaceutical, biotechnology or CRO experience preferred)
  • Responsible for Trial Master File (TMF) quality for sponsor and/or CRO studies
  • Assist in Periodic audits of client TMFs as well as internal TMF audits
  • Prepare, process and track paper & electronic documents received as per project guidelines in a timely manner
  • Ensure documents are scanned, imported, coded, and indexed into the (e)Trial Master File and reviewed for quality on an ongoing basis
  • Archive all paper files and maintain an ongoing inventory list of all received files as per guidelines
  • Liaison with internal and regional teams to ensure completeness and quality of documents
  • Plan and perform periodical quality checks of (e)Trial Master Files & the Paper TMF Files to identify any filing issues experienced by the Clinical Trial Teams to ensure that both (e)Trial Master Files and Paper TMF Files meet internal and external quality standards
  • Assist in Training team members as well as other TransPerfect Life Sciences Production teams on essential documents and regulatory requirements
  • Participate in and become an expert on the TMF Reference Model and stay current on regulatory changes
  • Take a proactive role in learning about clients' industries, business needs and company culture, educating the project team, identifying new business opportunities and providing a high level of service
  • Ultimately responsible for submission and inspection readiness of the TMF
  • Minimum Associate Degree in Science, Preferred BS from 4-year college or equivalent
  • Minimum 3 years experience in the life sciences industry
  • Previous employment in Pharmaceutical, CRO or Medical Device industry
  • Previous experience overseeing TMF audits, internal and/or regulatory audits
  • Experience collecting, scanning and coding TMF documentation
  • Experience in overseeing and training employees on TMF SOPs and regulatory requirements
  • Proficiency in Adobe Acrobat Professional, ISI Tools and web-base document indexing and viewing application. Knowledge of scanning, extracting, uploading, OCR, rendering, bookmarking/linking, document verification and compiling
  • Proficiency in Microsoft Office (Word, Excel, Outlook), eTMF and eClinical technologies
  • Works well with people from a variety of different backgrounds and cultures
  • Builds relationships with clients and co-workers
  • Takes active measures to solve problems and commit to a high level of service

Ctrc Clinical Trials Operations Manager Resume Examples & Samples

  • Develops operational policies and procedures to standardize the responsibilities and communication between the research team and CTRC services to ensure operational compliance with Food and Drug Administration, National Clinical Investigator and other federal and institutional guidelines
  • Reviews and is familiar with all protocols that take place in the CTRC. Works to assure compliance with study related activities performed in the CTRC through protocol binders, training logs and delegation logs
  • Coordinates with PI’s and study teams and UCH CTRC Clinical Research Staff on administrative issues related to clinical research
  • Under the direction of the CCTSI Director of Operations, provides leadership, management and oversight to facilitate efficient and effective administrative operations including fiscal, information technology, facilities, personnel, contracts, Clinical Trial Management Systems (OnCore) and infrastructure management
  • Establishes and maintains high levels of bi-directional communication and collaboration between the CTRC Clinical Trials Support Services, UCD Clinical Research Support Center and UCH Research Support Services regarding issues relevant to active and pending clinical research protocols, patients participating in UCH CTRC clinical research protocols, coordination of support services, etc
  • In collaboration with CCTSI Director of Operations, the UCH CTRC Medical Director, and the CRSC education team, develops and implements trainings in clinical research for Investigators and their staff
  • Prepares reports and collects metrics for quality improvement and to support the grant. Also prepares regular reports of actual and projected utilization of the Clinical Trials Support Services
  • Collaborates with PI’s, UCD CRSC, and UCH RSS in developing accurate projections of protocol related budget items
  • Collaborates with CCTSI Administrative Director and the CCTSI Director of Operations, in developing accurate projections of expenses, budgetary, and staffing needs relating to clinical research services provided by the CTRC
  • Works with the leadership of the CCTSI to support NIH/NCATS Network clinical trials including the use of the NCATS SMART IRB model
  • Serve as the Clinical Trials Liaison to NCATS for UCD
  • Master’s degree in a health, science or research field
  • Experience working in an academic institution
  • Experience with research budget and grant development for sponsored projects
  • Experience with NIH-sponsored and industry clinical research studies, including multi-center clinical trials
  • Prior experience as a research coordinator
  • Advanced knowledge of all aspects of clinical trials implementation including Good Clinical Practices, FDA rules and regulations in relation to clinical trials, ICH regulations, and all other applicable areas of research compliance
  • Excellent interpersonal oral and written communication, organization skills, and ability to problem solve and multi-task
  • Knowledge of the academic center regulatory and clinical processes as related to clinical research
  • Ability to work with physicians and nurses in a clinical research setting
  • Must be able to work under pressure in a deadline oriented environment

Clinical Laboratory Information System Program Manager Resume Examples & Samples

  • Master’s degree in Laboratory-related Science, Informatics/Information Systems, or Computer Science
  • Three (3) or more years’ of experience as an Anatomic Laboratory System Analyst or equivalent position
  • Experience with building or managing Cerner CoPathPlus strongly preferred
  • Experience with integrating/interfacing an AP-LIS with an Epic EHR environment
  • Experience with SQL queries and report writing tools
  • Ability to analyze, evaluate and plan for the information technology support required by an organization in the present and future
  • Skilled in effective communication with University faculty, staff and students
  • Demonstrated ability to meet deadlines and to follow through with assignments in a timely and professional manner
  • Ability to quickly learn and apply new technologies
  • Demonstrated experience working with diverse populations in a multi-cultural environment that is committed to diversity and equality in education
  • Must be able to work effectively as part of a team and foster a positive team environment
  • Proven ability to take direction well and be a motivated self-starter
  • Experience creating and managing IT policies and procedures
  • Knowledge of college and university policies and environments

Academic Clinical Nephrologist Resume Examples & Samples

  • Substantial outpatient clinic time
  • Outpatient chronic dialysis shift(s)
  • Occasional attending on the inpatient renal consult and hospitalist services
  • Some holiday and weekend inpatient coverage
  • Didactic interaction with students, residents, and renal fellow’s clinics
  • Formal teaching such as attending morning report,
  • Renal Grand Rounds, clinical conference, and journal club
  • Attendance and participation at daily educational conferences
  • Board Certified in Nephrology
  • Strong medical knowledge in the diagnosis and management of CKD, ESRD, glomerulonephritis, and other common outpatient renal problems
  • Strong medical knowledge in acute kidney injury, electrolyte abnormalities, and acid-base disorders
  • Successful completion of Nephrology fellowship training
  • 1-2 years of experience as a practicing nephrologist
  • Directing the didactic and clinical aspects of the advanced education program in Prosthodontics, including recruiting, instruction, supervision and mentoring of postdoctoral students
  • Preclinical and clinical teaching of fixed, removable, implant prosthodontics, and implant surgery; and
  • Participation in the department’s intramural faculty practice
  • Education Requirement
  • DDS/DMD or foreign equivalent
  • Master's Degree or Certificate in Prosthodontics from an ADA-accredited dental school; and
  • Strong written and verbal communication and working with global teams - setting clear expectations, ensuring proper follow-up etc
  • Adept in eDC systems - RAVE
  • Data Management experience
  • Effective vendor management skills
  • Must have high level global experience
  • Strong interpersonal and communication/ presentation skills (verbal and written)
  • Ability to handle multiple tasks and to prioritize, strong organizational skills
  • Leadership & Project Management skills; positive, "can do" attitude, includes effective vendor and stakeholder management, risk management planning, active and effectual oversight of CROs,…
  • Decision-making and problem-solving skills
  • Good cross-functional team leader who fosters team spirit and team motivation (team work)
  • Understanding of database concepts preferred

Clinical Laboratory Tech Hmc Resume Examples & Samples

  • Associates or Bachelor degree in science
  • Experience in major medical hospital laboratory
  • Experience with laboratory information system
  • Ability to communicate effectively in, both verbally and in writing

Clinical Application Consultant Resume Examples & Samples

  • Review and assist customers with their protocols and assays on Ion Torrent / Thermo Fisher instrumentation at in-house facilities and at customer sites
  • Help customers design, conduct and analyse experiments to assist in evaluations of Ion Torrent / Thermo Fisher products, with strong focus on analysis and interpretation of data
  • Promote new products (clinical solutions) on customer sites and in conferences/user meetings
  • Work in collaboration with the Clinical Account Manager to set up best strategy for customer site
  • Build strong relationships with customers
  • Maintain consistent and structured communication with counterparts and articulate summarized communication to Manager on a periodic basis
  • Estimated 30-50% travel,

Clinical Trial Coordinator Resume Examples & Samples

  • Good written and oral communications skills with understanding of written and oral English
  • Self starter and proactive self learner
  • Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, Powerpoint
  • Experience supporting teams highly desirable
  • Organize/maintain administrative activities/systems to support department members including compiling, analysis, tracking, filing and other functions as required
  • Open, sort and distribute mail, fax documents, keep files, order office supplies and maintain supplies
  • Responsible for scheduling, organizing, and coordinating logistics for on- and off-site staff meetings
  • Responsible for logistics of meetings with internal and external partners, including scheduling meetings and hosting the visitors
  • Coordinate agenda for, schedule and organize (including conference dial in) meetings as required
  • Manage staff calendars, updating monthly schedule, and arrange travel itinerary and related activities
  • Prepare presentation materials
  • Schedule interviews for candidates
  • Conduct additional tasks as may be required by the Clinical Operations Leadership team

Financial Analyst, Clinical Solutions Resume Examples & Samples

  • Personal drive: technical & professional expertise, practice self-development, ability to work in culturally diverse environment, intellectual curiosity
  • Interpersonal skills: excellent communication skills, collaboration and teamwork, ability to work with different levels of organization, critical & convincing
  • Drive change: champion change, seek to uncover issues and make improvements
  • Results oriented: customer focused, drives for results, problem solver, analytical and structured, ability to work to tight deadlines, planning and organizing skills, high level of resilience
  • Must be a quick study, have excellent business acumen, and be able to react quickly and effectively to changing circumstances
  • Bachelor's degree in Finance, Accounting or related area
  • Minimum 3 years relevant experience in an accounting and/or financial analyst role required
  • Strong analytical skills, a self-starter with "can do" mentality; quick learner in a complex and demanding environment
  • Excellent knowledge and understanding of financial and management accounting, process and systems
  • Must be precise and demonstrate strong attention to detail
  • Affinity with large and complex international working environment
  • Commercial and organizational awareness, ideally in a comparable industry
  • Must be an advanced level Excel user. Experience with manipulating large amounts of data and PowerPoint, Hyperion, and Oracle knowledge are required as well as the ability to quickly learn new systems/tools

Merchant Clinical Skincare Resume Examples & Samples

  • Developing and executing overall strategy for growth with new product introductions and strategic expansion of current brands
  • Establishing and managing brand relationships, inclusive of terms negotiations (margin, testers/damages, training support, co-op, RTV's, samples, and more)
  • Developing and leading assortment and plan promotions, launches, animations for brands within skincare category strategy
  • Analyzing all elements of the category to identify areas of opportunity
  • Sourcing and developing new brands that fill an important need gap within the category
  • Interpreting and communicating direction to team members within business unit to ensure that each initiative is developed within the desired timeline
  • Communicating brand and business opportunities to our stores
  • Leading fixture/plannogram planning and implementation with internal partners
  • Planning promotions, launches, animations and marketing activities with variety of internal partners
  • Communicating training needs to brand partners and Sephora education team
  • Managing brand fill rate and P.O. fulfillment with inventory management team
  • Constantly developing, mentoring, and training team
  • Championing a work environment that embodies the Sephora values (teamwork, innovation, expertise, work-life balance, respect for all, initiative, and passion)

Clinical Associate Resume Examples & Samples

  • Provide professional clinical support to new and existing customers (primarily physicians) on our three-dimensional mapping system, Carto 3 inclusive of electro-anatomical mapping. Support on the full BW product portfolio and hardware relating to Electrophysiology procedures will also be required
  • Act as the first point of contact to Biosense Webster customers for the territory covered
  • Demonstrate the ability to support the sales target and help manage the defined territory in a thoughtful and strategic manner in collaboration with the Product Specialist
  • Act as a technical resource through education and training relating to Carto 3, BW products, ablation, and electrophysiology procedures with new and existing customers (primarily physicians, nurses and technologist) in groups and 1-on-1
  • Build relationships with Key Opinion Leaders and other targeted customers in order to ensure delivery of high quality clinical support and to become an extension of a collaborative field force and Electrophysiology lab team
  • Technical Qualification in Cardiovascular Technology, RN, PA-C, CNP and/or University Degree preferably in Science or Business is required
  • Certification through the IBHRE “Cardiac EP for Allied Professionals” will be considered an asset
  • 1-2 years of Clinical experience in the field of cardiology, electrophysiology, cardiovascular care, or medical device industry would be an asset
  • Willingness to work within a lab or operating room (OR) environment
  • Candidates must have a valid driver's license
  • Ability to travel up to 30% is necessary, which may include overnight and/or weekend travel as dictated by the customer and business needs
  • Candidates must possess superior written and oral communication skills that would allow them to communicate effectively with both technical and non technical audiences
  • Results and performance driven with a bias for action and sense of urgency on priorities
  • As driving is an essential requirement of the role, a safe driving record as per Johnson & Johnson SAFE Fleet guidelines

Clinical Team Asst-casual Resume Examples & Samples

  • Staffs all assigned schedules with appropriate personnel
  • Establishes/maintains work schedules
  • Process charts, orders, training sessions, team meeting information and other tasks as assigned

IC Clinical Resume Examples & Samples

  • Serves as primary resource for clinical support in the areas of case coverage, basic troubleshooting, specialty product usage and customer training
  • Educates customers on the merits and proper clinical usage of company products by giving presentations and demonstrations using a wide variety of formats and platforms. Provide supplemental training support during product launches and for high touch specialty products (filter wire / rotablator)
  • Responds to customer needs and complaints regarding products and service by developing creative and feasible solutions or working with other related personnel to develop optimal solutions (especially training, troubleshooting and general case support for iLab hardware / IVUS)
  • Previous Cath Lab or Cardiovascular experience
  • Strong clinical aptitude
  • Problem solving and the ability to be coached and directed by other teammates will allow collaboration and success in selling IVUS, DES, balloons and the full bag of specialty products
  • Develop and maintain positive relationships both internal and external to project, including site personnel
  • Learn clinical project management processes and therapeutic area basics
  • Become familiar with and follow appropriate SOPs
  • Participate in clinical study core team meetings, and record, issue and file minutes of study-specific meetings
  • Support the CPM in collection of pertinent Regulatory documents from initial trial start-up through trial close out
  • Ensure central and site file documentation is appropriately tracked and filed, and support the CPM in ensuring that documentation complies with ICH/GCP, BSC and project specific requirements
  • Reconcile and inventory study documentation periodically and for archiving at study close-out
  • Utilize specified clinical project systems and tools for documentation management
  • Assist CPM in completing literature searches and reviews
  • Support the CPM in development and execution of clinical study contracts and budgets. Report relevant status updates/metrics to the study team as per study-specific requirements
  • Lead ongoing maintenance of study contracts and budgets
  • Support the CPM in initiating and tracking IRB/EC submissions, approvals and renewals
  • Prepare and distribute site Regulatory binders
  • Track and execute payments to investigational centers and vendors under supervision of the CPM
  • Initiate study device shipments to and returns from approved sites
  • Set up SAP for clinical trial shipments
  • Facilitate investigational device traceability and generate reports as needed
  • Prepare and ship study supplies to all study clinical trial sites as needed
  • Support data management and analysis activities as needed under guidance of the CPM
  • Support protocol adherence through clinical database review and follow-up with clinical trial sites as needed
  • Identify and Report complaints per Corporate SOP requirements
  • Ensure timely communication of the need for corrective action at clinical sites or with a BSC process to management
  • Ensure training (including project specific) is completed per the required timelines and project needs
  • Other Clinical administrative duties as needed
  • AA Degree or equivalent work experience in related discipline, Bachelor degree preferred
  • 3 years of related experience, 1+ years relevant clinical experience required
  • Data related experience preferred
  • Therapeutic insight with regard pulmonary illnesses (e.g., asthma & lung cancer)
  • Minimum of 6 months experience in utilizing BSC’s controlled document management systems
  • Minimum of 6 months experience in administering study site payments (US and OUS) as triggered in BSC’s CTMS environment
  • The ability to support multiple pulmonary studies simultaneously
  • Demonstrated ability to maintain and develop clinical study master files for ongoing and new clinical studies

Clinical IT Liaison Manager Resume Examples & Samples

  • Investigates current issues and assists in understanding the impact to field Users IT system changes
  • Translate between IT and business/clinical teams
  • This position requires use ability to function at an advanced level in Microsoft Excel and Word and ability to learn additional IT systems quickly
  • Bachelor’s Degree in related field
  • Minimum of 5 years of clinical experience in dialysis/nephrology
  • Advanced level of proficiency in MS Office Suite (particularly MS Excel)
  • Ability to learn additional IT systems and software quickly
  • Travel requirement: up to 50 %

Senior Analyst, Clinical Programs Resume Examples & Samples

  • Create, maintain, and distribute reports related to clinical outcomes, surveillance, and risk mitigation on a regular basis
  • Provide critical insights and data trends to support and inform a multitude of projects and initiatives across the organization
  • Act as a thought leader and collaborative partner during strategy meetings
  • Independently drive multiple projects simultaneously
  • Present data to and work closely with a variety of stakeholders including senior-level operators and teammates in the clinics
  • Create cohesive presentations based on findings, summarizing insights from analyses
  • Coach junior analysts and assist in developing their analytical and professional skills
  • Advanced proficiency in MS Office applications required (MS Excel, PowerPoint, Word, and Outlook)
  • Intermediate level of proficiency/familiarity with SQL required
  • Familiarity with more advanced reporting tools (such as Tableau and Cognos) preferred, or willingness to learn
  • Experience in creating and leading presentations directed towards senior leadership
  • Knowledge of Business Intelligence and Data Architecture terminology/practices
  • Ability to quickly adapt to and pick up on new technologies and techniques
  • Competency in process and performance improvement
  • Travel required: up to 10%
  • Bachelor’s degree required; major in biostatistics, statistics, informatics, computer science, math, or relevant field a plus; Master’s degree a plus, but not required
  • Minimum of 2 years of relevant experience required
  • SQL, Microsoft Excel, PowerPoint proficiency required
  • VBA, R, Stata, Matlab, SPSS/SPSS Modeler, SAS, Programming language (Python, C++, C) experience a plus; willingness to learn required

Clinical Investigation Tech Resume Examples & Samples

  • Recruits and screens volunteers for studies
  • Advertises: following established guidelines and a study budget, creates and places advertising for study participants; helps devise recruitment strategies; explores new methods of participant advertising and recruitment
  • Screens: following study-specific steps and standard guidelines, answers telephone calls and emails, informs potential participants about the study, schedules screening visits with participants, laboratory facilities, and professionals, reviews screening questionnaires for completeness, scores questionnaires, ensures all screening steps are completed, seeks advice from appropriate study team member on questions related to inclusion/exclusion or appropriateness of participants for studies. May be required to perform clinical tests such as EKGs, vision tests, and/or psychological questionnaires
  • Schedules: schedules all screening visits for potential participants with laboratories, medical professionals, study investigators; schedules all study-related procedures with participants, investigators, laboratories, and others required to carry out study. Schedules and attends study team meetings, including preparing agendas, taking minutes, etc. Serves as overall coordinator for scheduling all aspects of study
  • Maintains records: following established procedures, responsible for maintaining screening records for each participant; responsible for maintaining necessary records and documents to meet regulatory (IRB, DHHS, DoD) guidelines. Assists investigators in preparing monthly and annual reports to meet regulatory requirements. Prepares and presents weekly reports for study team meetings
  • Interacts with human research subjects to administer tests, collect data, ensure adherance to protocol
  • Physiologic data collection: uses equipment and sensors to collect physiologic signals from study participants following standard or study-specific procedures. Able set up equipment, troubleshoot equipment and sensor problems, download data, with minimal supervision
  • Biological specimens: collects and prepares urine, blood and saliva samples from study participants for later assay; transports specimens between locations using standard procedures; ships specimens using standard procedures
  • Performance tests and questionnaires: monitors computer-controlled administration of neurobehavioral tests using central data collection systems; recovers computers after system failures according to standard procedures with minimal supervision. Administers written tests and questionnaires using standard procedures. Administers tests using stand-alone computers and software
  • Subject monitoring and protocol execution activities: ensures study protocol events are carried out as scheduled in study orders and/or event scheduling system and occur on time while following SOPs; uses data collection systems to collect and record key study information according to CCI, DSCD, and study SOPs; monitors study participants to ensure they comply with study protocol and they remain in good health; communicates any deviations in study protocol, equipment malfunctions, and participant discomfort or complaint to the appropriate CCI, DSCD, and study personnel; provides feedback on areas of workflow improvement and quality improvement
  • Organizes and processes study data
  • Creates and maintains databases/files containing study data using standard Division practices
  • Scores written tests and questionnaires using standard score sheets and criteria; enters scores into worksheets and databases
  • Compiles data from multiple testing sessions/subjects for data analysis
  • Reviews study records to determine whether specific tests, samples, or other data were not collected according to protocol, enters such information into tables, edits such information from dataset copies using standard Division practices
  • Performs statistical and graphical analysis
  • Assists Investigators and other study personnel in executing studies
  • Assists in preparation of IRB, CTSC, and other applications, as well as grants
  • Maintains and orders supplies, prepares equipment, and ensures other materials for conducting studies are available in the correct location at the time needed
  • Drafts and/or modifies written procedures for study-specific events/data procedures
  • Carries out standard and study-specific events as outlined in the study orders, DSCD/CCI SOPs, and other written documents
  • Acts as a liaison between Investigators, hospital staff, CCI technical staff, administrative staff, subject recruiters, and research subjects to identify areas for quality and workflow improvements
  • Assists Investigator in research activities
  • Maintains records, keeps inventories, prepares invoices, places purchase orders, and reconciles expenditures and income for specific projects
  • Performs literature searches, reviews literature, enters papers into reference database, compiles and checks reference lists for manuscripts, grants, and other written reports
  • Drafts text for reports, manuscripts, abstracts, grants
  • Assists in orienting and training new employees
  • Follows Infection Control, Electrical Safety, Radiation Safety and other guidelines as mandated by BWH, OSHA, or other regulatory agencies; follows HIPPA and Human Research guidelines as mandated by DHHS. Follows all standard operating procedures for the Chronobiology Core of the Division of Sleep Medicine, the Center for Clinical Investigation, and BWH; follows study-specific procedures
  • Performs all other laboratory duties and projects as assigned
  • Bachelor’s degree in health science, biology, neuroscience, psychology or related area, or equivalent experience preferred
  • Strongly prefer individual with prior experience working with subjects/patients, and working on a research team
  • Prefer individual with minimum of 3 months of experience as a technical staff member in the Division of Sleep Medicine, CCI, or equivalent research facility
  • Prefer individual with independent research experience (e.g., thesis project)
  • Excellent interpersonal skills, able to maintain positive working relationships with co-workers and to work cooperatively with peers, able to perform his/her role in a team effort
  • Excellent organizational skills, and ability to prioritize and manage time efficiently
  • Excellent reasoning skills. Ability to exercise initiative and sound judgment in unexpected situations
  • Highly competent with using and trouble-shooting computers and equipment
  • Physically able to assist with the moving of testing supplies and equipment
  • Willing to accept additional work (new projects, overtime) when required
  • Ability to continually learn new technical skills and update existing skills
  • Able to learn and use a variety of software programs
  • Ability to teach peers, graduate students, post-doctoral fellows, and other researchers technical knowledge and skills

Clinical Investigation Technicians Resume Examples & Samples

  • Coordinates the implementation of research studies both within the BWH community as well as with external vendors, professionals, and stakeholders
  • Develops, organizes and/or maintains participant information database for study to meet internal (department, Human Research Committee) and external (NIH, FDA, etc.) guidelines and requirements. Required to input and check data, and prepare and present weekly, monthly and annual reports
  • In conjunction with the Project Leader, develops and prepares materials necessary for the implementation of research protocols including study design, data collection systems, and methods, etc
  • Responsible for study specific equipment and for assisting Project Leader in testing, setting up, and training other staff on study equipment. Monitors study events and data collection activities during the study
  • Assists PL(s) in organization, cleaning/editing and analysis of data during and/or following the study
  • Assist the Principal Investigator/Project Leader with preparation of study generated information for presentations and manuscripts
  • Ability to work independently in a busy, open office setting with several other employees
  • Excellent interpersonal skills are required
  • Ability to learn and understand clinical research protocols and study goals
  • Ability to maintain good working relationships within the Division and with staff members in other departments
  • Knowledge of computer programs, database, etc
  • Excellent organizational skills and ability to prioritize a variety of tasks
  • Careful attention to detail
  • Ability to demonstrate professionalism and respect for subject rights and individual needs and to maintain confidentiality
  • Must be able to be HIPPA compliant at all times
  • Ability to learn new technical skills and perform them with competency

Clinical Performance Analyst Resume Examples & Samples

  • Bachelors Required in an informatics related field
  • Masters Preferred in an informatics related field
  • 5 plus years working with complex data environments or systems
  • Critical thinking abilities
  • Experience/Understanding with SAS

Clinical Performance Assessment & Improvement Director Resume Examples & Samples

  • Responsible for oversight and assessment of clinical performance data and care delivery practices. Collaborates with administrators, physicians, clinical leaders and staff to identify improvement opportunities utilizing quantitative techniques, knowledge of health care operations and systems thinking. Obtains and uses literature, evidence-based practice and benchmark data whenever possible
  • Improves clinical performance: identifies causes of variation, serves as a subject matter expert and supports implementation of systems and processes to facilitate effective clinical practice. Leverages results from Peer Review, Regulatory, Patient Safety and others to align performance improvement opportunities with system and local teams
  • Facilitates prioritization of improvement activities with system and entity leadership. Conducts in- depth assessment of qualitative and quantitative data. Triangulates information to support administrative and clinical decision making. Collaborates with the appropriate process owner(s) to identify opportunities for improvement
  • Establishes and oversees the development and implementation of annual quality plans with administrative, service line and process owners. Strategizes with entity leadership to plan and coordinate local Quality Councils
  • Manages and coaches performance improvement activities and oversees projects in collaboration with project leaders and administrators. Serves as a resource and/or facilitates improvement teams to plan, implement, and coordinate entity activities to maximize clinical and operational outcomes. Participates on improvement teams, guiding teams on system defined improvement methodologies and processes
  • Maintains clinical performance assessment, performance improvement, change management and project facilitation expertise through independent study, internal development courses, attending education workshops, reviewing professional publications, establishing personal networks, and participating in professional organizations
  • In some settings, responsible for recruiting, selecting, developing, mentoring, supervision and assessment of staff. Also responsible for creating and managing departmental budgets

Clinical Delegation Oversight Auditor, Senior Resume Examples & Samples

  • Review of clinical functions and collaborates with other departments and/or delegated vendors to direct clinical compliance issues to appropriate channels for investigation and resolution. Consults with management, in-house counsel, delegated vendors, and/or the VP of Regulatory Compliance as needed to resolve difficult compliance issues
  • Regular interaction with all departments, management, associates, delegated vendors, and/or regulatory agencies regarding compliance issues
  • Review and evaluate the effectiveness of corrective action plans that address audit report findings and provide comprehensive follow-up to Senior Management, market Compliance oversight Committees, and/or the Regulatory Compliance Committee of the Board of Directors
  • Track the status and completion of all corrective action plans and ensure the implementation of all recommendations derived from each focused review, oversight and/or monitoring activity
  • Evaluate the effectiveness of various compliance programs and related policies and procedures designed to promote legal and ethical compliance
  • Identify and assess compliance risks within the Company and/or with the Company’s delegated vendors
  • Serves as a compliance advisor to various business units or delegated vendor
  • Participates in the ongoing development of educational and training tools for the Compliance Program that seeks to ensure all associates are knowledgeable of and comply with pertinent Federal and State laws and regulations
  • Assists with the development, initiation, maintenance and revision of Compliance Program policies, procedures and practices for the general operation of the Program
  • Assists Corporate Audit & Oversight management with the development and execution of key departmental initiatives
  • May participate in special projects as needed including auditing, training, and HIPAA compliance
  • Communicates the importance of compliance and the compliance program to health plan staff and/or delegated vendors, which includes promoting (1) increased awareness of the Corporate Ethics and Compliance Program, (2) understanding of new and existing compliance issues and related policies and procedures, and (3) importance of oversight and monitoring activities
  • This position serves to educate, encourage and assist those within the Company and with the Company’s delegated vendors to maintain integrity through oversight and monitoring and in meeting the requirements of the Annual Work Plan within State Medicaid Programs, OIG and CMS work plan requirements
  • Provides education and training about laws and regulations that affect operations internally and/or through delegated vendor relationships
  • Provides guidance, direction and mentoring to lower level staff members
  • Performs other duties as may be assigned
  • Required An Associate's Degree in Nursing, Pharmacy, or Other Clinical related discipline and a Registered Nurse (RN), Licensed Vocational Nurse (LVN), Licensed Practical Nurse (LPN), or Licensed Clinical Social Worker (LCSW) designation
  • Preferred A High School or GED Business, Public Health, Health Care Administration
  • Required 5+ years of experience in Managed Care/Health Insurance
  • Required 2+ years of experience in a project oversight type role with demonstrated ability to drive implementation and influence others
  • Required 3+ years of experience in Experience in State Medicaid or Federal managed care compliance
  • Preferred Other Previous experience managing compliance issues via audit/compliance platforms
  • Intermediate Knowledge of community, state and federal laws and resources
  • Required Licensed Vocational Nurse (LVN)
  • Required Licensed Specialist Clinical Social Worker (LSCSW)
  • Required Intermediate Microsoft Project
  • Required Intermediate Microsoft Access
  • Preferred Intermediate Healthcare Management Systems (Generic)
  • Required Intermediate Microsoft PowerPoint

Clinical Educatior Resume Examples & Samples

  • Assesses, plans, directs and evaluates educational needs for the clinical care area(s) assigned
  • Provides educational programs based on the needs identified in the clinical care area
  • Develops/modifies the clinical orientation program of all new nurses, including cross training to the different areas as designated
  • Ensures that the educational needs of all shifts are addressed. Ensures competency of staff by serving as resource by assisting in the development of individual nurses to maintain staff competency
  • Assists nursing staff with assessment of patient/family care/educational needs on selected cases and collaborates with nursing staff and other health care professionals to meet identified needs
  • Participates in the development/evaluation of Patient Education/discharge planning aspects of care
  • Assists with the development and implementation of nursing intervention and patient care strategy
  • Utilizes knowledge of the developmental levels of the patient and age related factors in order to support staff through education to care for these patients. Interprets, evaluates and communicates pertinent research findings to nursing staff through in-services and scheduled programs regarding issues in Patient and Family Care
  • Presents formal and informal education to the nursing staff, patients and family in clinical setting
  • Presents classes related to clinical specialization to staff, students and other health care professionals as needs are identified
  • Encourages the use of and integrates online education
  • Ensures the education requirements for Governing Board/Regulatory Agencies are met
  • Collaborates with Nurse Directors, Infection Control, Quality Improvement Director, physicians, and other health care professionals to identify educational needs and provide online education support to clinical staff
  • Serves on other committees or task force
  • Participates in professional organizations in order to expand knowledge base and develop professional contacts
  • Education experience for approximately 2-5 years
  • Minimum of 2 years of nursing specialty experience required, with the ability to apply theory related to practice and performance of required technical skills
  • Experience in the development of educational programs required
  • Working knowledge of Quality Improvement process and Joint Commission standards
  • Able to relate to a large variety of individuals
  • Clinical and operational experience in the respective field or specialty
  • Physical Requirements: Ability to work at a fast pace and to prioritize multiple assignments/projects and respond to numerous requests; ability to resolve conflicts among staff and to work collaboratively with department director, physicians and other members of the healthcare team; ability to ensure operational efficiency; ability to problem solve and make decisions; ability to exercise self-control and tolerate stress when dealing with multiple requests and/or conflicting demands from multiple customers
  • Needs minimal sustained direction in assessing needs, directing staff and carrying out departmental and professional responsibilities; self-starting and self-motivating; working hours may exceed eight hours per day and is based on what is needed to accomplish work at hand
  • Able to be flexible with time

PA Allergy, Asthma & Clinical Immunology Resume Examples & Samples

  • Collaborates with referring physicians to provide comprehensive, seamless care to patients in the outpatient setting
  • Performs comprehensive histories and physical exams, identify normal and abnormal findings, including physical, cognitive and psychosocial status
  • Partners with providers to plan and implement therapeutic regimens including nursing and medical management strategies
  • Establishes systematic follow-up for evaluation of the plan of care and reassess as necessary
  • Assures family and patient teaching is adequate to manage the plan of care at home
  • Functions independently in an outpatient clinic setting
  • Strong Internal Medicine experience
  • Excellent verbal, written and oral communication skills

Clinical Laboratory Technologist Resume Examples & Samples

  • A two-year commitment to this position is required.**
  • The required credits necessary to meet New York State guidelines pertaining to clinical testing must be met prior to graduation**
  • Transcripts (unofficial copy accepted)

Senior VP Clinical & Formulary Services Resume Examples & Samples

  • 10+ years of clinical and/or managed care pharmacy experience
  • 10+ years of leadership experience including managing leadership levels
  • 5+ years of extensive involvement in clinical pharmacy strategy
  • 5+ years hands on experience with P&T and Formulary Management
  • Advanced degree/ MBA
  • Pharmacy Benefits Management experience

Clinical Analytical Consultant Resume Examples & Samples

  • Efficiently extract and manipulate pharmacy claim data for internal and external clients
  • Collaborate with the clinical account management team and other internal departments to support the analytic needs of one or more clients
  • Design, execute, and maintain advanced PBM analytics, conduct and evaluate trend analyses, and present clinical and financial opportunities based on analytic insights to clients
  • Use logic and analytic skills to perform client analyses in response to specific business questions and communicate the findings, including data sources, methodology, outcomes and recommendations
  • 7+ years of experience in quantitative analytics, conducting advanced analytic modeling for large claims databases with real - world application
  • 5+ years of experience working with administrative pharmacy and medical claims data
  • 1+ year of experience working in PBM and / or managed care
  • Experience preparing and giving formal presentations to clients
  • Proficient computer skills including in Microsoft Outlook and Office
  • Master’s Degree in Math, Statistics, Engineering, Computer Science, Public Health, Health Economics or a related quantitative field
  • Experience working with State governments contracts or large employer groups

Director of Optum Clinical Capability Management Resume Examples & Samples

  • Partnering closely with executives to understand enterprise clinical business and platform needs and proactively develop solutions to meet their needs
  • Understanding Optum business models, underlying business drivers, applicable industry and market needs
  • Providing innovative solution design and business architecture expertise and recommendations to solve complex business problems and deliver value. Acts as subject matter expert on Optum clinical capabilities and provides oversight on work in those areas to ensure we are not creating unnecessary, duplicative solutions
  • Collaborating with business and technology partners to determine priorities
  • Establishing and maintaining effective communication channels to ensure the customer and solution team is kept abreast of any key changes in strategy or solution direction
  • Partnering with finance and business operations leaders to complete capital planning activities and Cost Benefit Analysis deliverables (includes identifying cost avoidance, cost reduction opportunities)
  • Defining and managing strategic roadmaps for key Optum clinical capabilities
  • Leading capital projects supporting enterprise clinical initiatives from end to end (ideation through implementation and deployment). Ensuring successful execution on all responsible capital work streams and work streams that are impacting capabilities and platforms and overseeing the entire software development lifecycle
  • Managing a team of business analysts and project managers to support the execution of the clinical platform builds. This includes research & analysis, business requirements, design work, testing, deployment and support. May also include defining operational support for new capabilities including, governance, business operations team definition, steering and funding strategies
  • This position is located in Eden Prairie, MN
  • Leader with 12 + years of demonstrated progressive accomplishment in the following areas
  • Investigates non-standard requests and problems, with some assistance from others
  • Works exclusively within a specific knowledge area
  • Serves as product subject matter expert and liaison for internal staff and external customers
  • Serves as liaison for strategic initiatives crossing business teams and operating groups to coordinate and complete product and business development initiatives
  • Works to further establish processes and structure within our existing business unit to help create efficiencies within our products
  • Investigates processes and problems by leveraging data and facts, identifying the key team(s) to solve problems or create processes, and documenting clearly and concisely
  • Monitors and measures effectiveness of product and strategies and provide recommendations to adjust as necessary
  • Develops and implements new programs and processes
  • Bachelor's Degree in Business, Finance, Communications, or Marketing
  • 4 years of product management experience within a matrix organization
  • 2+ years of experience in tracking, planning projects, working with large data sets
  • 2+ years of Product Development experience
  • Demonstrated ability to manage and prioritize deliverables
  • Intermediate level of proficiency with MS Project, Excel, Visio, PowerPoint and SharePoint
  • Experience with project management and complex projects and activities
  • Strong background and / or understanding of the healthcare industry
  • Knowledge and experience with the Health Care industry
  • Strong focus on execution and delivery
  • Excellent time management skills with the ability to self-manage according to priorities
  • Strong problem solving skills, ability to translate complex to easily understandable actionable terms
  • Ability to thrive, quickly adapt to change - and lead others through change - in a dynamic, fast-paced industry and matrixed work environment
  • Exceptional interpersonal, social and conflict management skills
  • Demonstrated effectiveness building strong relationships with inter-company divisions

Director of Clinical Resume Examples & Samples

  • At least 5-10 years of experience in the behavioral health field inclusive of at least 5 years in an inpatient facility;and a minimum of 3 years management experience
  • Experience in providing project management in multiple facilities or programs simultaneously
  • Demonstrated leadership ability in the areas of initiating program assessment and implementing quality program evidence-

Clinical Risk Manager Resume Examples & Samples

  • Two to five years experience within a hospital risk management with a focus on patient safety, risk management or quality improvement. Experience and/or demonstrated understanding of root cause analysis and FMEA analysis
  • RN preferred or other Clinical/Hospital background to provide for appropriate investigation of clinical events
  • BS required
  • Strong interpersonal skills, ability to work across disciplines
  • Ability to analyze data, formulate meaningful information
  • Ability to work with highly sensitive and confidential information with appropriate discretion
  • Training in patient safety or risk management and quality/performance
  • Improvement methodology, concepts, education and implementation
  • Membership and active participation in professional organization(s)
  • MS or JD preferred
  • Certified Professional in Healthcare Risk Management (CPHRM), preferred

Clinical Fellow, Speech Pathology Resume Examples & Samples

  • Master's degree in Speech Pathology from an accredited program of speech language pathology
  • Current California Speech Language Pathologist license or temporary license preferred
  • Minimum level of experience: new graduate
  • Must have one continuing education course for each year of practice
  • Must have manual and physical skills to perform high quality patient care with patients of any weight or age with multiple diagnoses

Clinical Trials Budget & Coverage Analyst Resume Examples & Samples

  • Must have two or more years of experience in clinical research administration or financial management
  • Must have one or more years of experience with budget negotiations for industry sponsored research
  • Two or more years of experience in human subjects’ protection regulatory analysis is desired
  • Certification in medical coding is desired
  • Experience with EPIC is desired
  • Must have knowledge of Centers for Medicare and Medicaid Services (CMS) Clinical Trial Policy, Medicare benefit categories, statutory exclusions, national and local coverage determinations and of national medical practice guidelines, Food and Drug Administration investigational drug and device research
  • Must be knowledgeable about medical coding, protocol visit span allowances, protocol-specified clinical services, and clinical research financial activities and documentation required before study initiation, including research protocol, internal budget, sponsor contract and budget, and consent template
  • Demonstrated budgetary and strategic planning experience and responsibilities
  • Demonstrated resourcefulness and meticulous attention to detail
  • Proven ability to work effectively with both technical and non-technical personnel
  • Demonstrated excellence in written, oral, electronic communication and presentation skills; scientific writing skills desired
  • Able to use multiple technical systems as intended; ability to collaborate across revenue cycle, compliance, and research operations teams
  • Ability to review complex documents independently and/or in collaboration with research administrators, and determine sufficiency of financial documentation
  • Ability to conduct research independently to identify and document evidence of medical necessity and federal billing status of clinical trial protocols
  • Excellent analytical, budgeting and computer skills, including Intermediate/Advanced Excel skills
  • Requires ability to work independently and to accept responsibility for complex and sensitive decision-making as it relates to the position
  • Must have outstanding organization skills to manage competing timetables and responsibilities

Clinical Finance Operations Analyst Resume Examples & Samples

  • Bachelor’s Degree in accounting, finance or related business discipline
  • 2 years of professional work experience
  • Excellent communication and facilitation skills
  • High level of collaboration and teamwork proficiency
  • Proficient with Microsoft Outlook, Word, Excel, PowerPoint, and Visio
  • Understanding of multi-dimensional databases and related data extraction
  • Proven analytical approach to problem solving and decision making

Clinical Decision Resources Lead Resume Examples & Samples

  • A minimum of an advanced degree (e.g., PharmD., MPH, MD) is required
  • A minimum of 6 years of relevant experience in Medical Information with strong communication (written and presentation) skills or experience with a drug Compendia is required
  • Understanding the uses of evidence-based medicine, comparative effectiveness, drug compendia, and care pathways for health care decision-making is required
  • Expertise in the healthcare industry, clinical knowledge or practice across multiple therapeutic areas is strongly preferred
  • Working knowledge of United States health care systems and payers - specifically understanding business models and perspectives of managed care and public sector - is preferred
  • Demonstrated excellence in leadership, including

Clinical Protocol Developer Resume Examples & Samples

  • Knowledge of medical terminology and treatment concepts
  • Understanding of national regulations regarding human subjects research
  • Understanding of AAALAC and USDA regulations regarding animal subjects research
  • Demonstrated ability to interact professionally and effectively with investigators, sponsors and cross-functional teams
  • Previous experience clinical trial protocol writing and editing
  • Knowledge of complex regulations, policies and procedures concerning the conduct of clinical trials, including FDA Good Clinical Practice (GCP) and IND requirements
  • Adept at intermediate level biostatistics
  • Knowledge of scientific writing, presentation and manuscript presentation
  • Will complete human subject protection training developed by the Collaborative Institutional Training Initiative (CITI), and NMCP research integrity training within one month from start date

Clinical Service Manager Resume Examples & Samples

  • Responsible for supervision of NPs and PAs in skilled nursing facilities in Western Washington and the Greater Puget Sound area
  • Building self-directed work teams with autonomy and accountability for their own goals/targets
  • Supporting and promoting organizational goals into specific goals and objectives for clinical staff
  • Developing and conducting programs that support and improve quality management and clinical performance of the Optum CarePlus clinical model in our partner skilled nursing facilities
  • Oversight and performance various administrative/operational functions to support the team
  • Providing clinical/health services expertise on business development efforts
  • Developing/strengthening relationships with various stakeholders
  • Analyze caseload assignments and make adjustments to shift assignments as needed
  • Promote collaboration among clinical and non-clinical staff
  • Strong supervisory, management and leadership skills
  • Certification as a GNP, ANP or FNP, or ability to obtain
  • Experience with electronic documentation and coding
  • Frequent Travel to facilities within territory
  • Current, unrestricted NP license in the State where position is located, or ability to obtain
  • Previous NP Supervision experience
  • Prior long term care NP experience

Clinical Standards SME Resume Examples & Samples

  • Reviewing the Study Reports, Report to Study Director for any discrepancy related to some discrepancy
  • Mapping of Raw Data (PDF Format) in CDISC SEND standards
  • Generation of Trial Design Domain (TA,TE,TS,TX)
  • Generation of PC-PP domain, This is completely done Manually
  • Mapping variables to controlled Terminology
  • Send Data-set generation
  • Validation and fixing errors and warnings in SEND domain
  • Preparing the Study Data Reviewers guide for the study
  • Generation of Define.XML
  • Placing the complete study package in eDOCS
  • Submitting the study package to Submission Operations (Regulatory)
  • Finally uploading the package in vDOCS with cover letter to Regulatory
  • Handling with multiple CRO and evaluating validation on their Study package
  • Reviewing CRO Data
  • Communication with CRO and Product Vendor

LTC Field Clinical Assessment Specialist Resume Examples & Samples

  • Identifies applicant's health needs and completes medical assessment of applicant
  • Coordinates with Care Management team and provides updates regarding member health status
  • Valid Drivers license may be required
  • Required An Associate's Degree in Nursing or related field
  • Required Other Current case management experience
  • Intermediate Ability to multi-task Ability to work independently, handle multiple assignments and prioritize workload

Clinical Team Leader Resume Examples & Samples

  • Regulatory Documentation - Independently resolves protocol questions with the Project Manager (PM) and patient related issues with the Medical Monitor (MM). Maintains a record of all contacts with the PM or MM concerning protocol deviations and clarifications
  • Monitoring - Develops clinical plans and guidelines, including clinical monitoring plans. Assures compliance with monitoring intervals according to the project requirements. Responsible for identifying best practices (geographically and therapeutically) within clinical monitoring and developing communications and training tools for the organization. Typically acts as Lead CRA on studies that are often larger or more complex global projects and programs
  • Line Manager - Responsible for the supervision and administrative oversight of all direct reports, which are most commonly CRAs and could include less experienced CTLs. Develops training plan and assures training compliance for all direct reports. Develops training plan and assures training compliance for all direct reports. Evaluates strengths/developmental opportunities of staff members. Evaluates and advises on strengths/developmental opportunities of staff members. Sets clear goals and objectives for all direct reports. Completes performance reviews and implements performance plans. Ensures CRA and CTL metrics are met. Meets regularly with direct reports to mentor them and to evaluate workload and metric compliance. Provides data for the maintenance of resourcing tools. Collaborates with study leadership/management to identify project resourcing demands, resolving potential resourcing conflicts and facilitating mutually beneficial resolutions. Meets and provides feedback to management on areas for process improvements and participates in process improvement teams. Evaluates staff's competency to perform on-site visits independently via sign-off visits according to published requirements. Participates in interviewing, collaborates with HR/Training in assessing initial training needs, and orientates new hires into the team and function. Facilitates teamwork; influences and motivates team to accomplish goals by encouraging direct and open communication, resolving conflict, and demonstrating support to team members. Ensures required on-site CRA assessment, sign-off, and documentation occurs. Provides strong leadership to the team, encouraging engagement, innovation and open communication, while implementing Company procedures

Clinical Ambassador Resume Examples & Samples

  • Responsible for providing consistent and effective updates to the Vice President of Clinical Services for all assigned responsibilities
  • Responsible for Oversight of Clinical and Regulatory Operations to include in-direct supervision of facility department heads
  • Responsible for Oversight and Performance Management of the Company’s Risk Monitoring effort with focus on specific regions including but limited to the following areas
  • Responsible for collaborating on clinically oriented census development opportunities (i.e. Clinical product development) and expense reduction opportunities (i.e. pharmacy reductions) in conjunction with the district/region operating teams
  • Responsible for implementing all Company Clinical and Regulatory Strategic Goals, including new or revised company systems, policies and procedures and programs
  • Monitors and encourages achievement of goals and objectives consistent with established company philosophy and standards of practice. Responsible for providing executive clinical leadership to certain defined operations ensuring an effective Quality Improvement Process with favorable clinical trends
  • Conducts Focus Compliance audits and Corporate Clinical Services Compliance audits as assigned
  • Regularly and consistently reviews clinical performance trends and indicators to identify trends. Provides necessary clinical leadership to address all unfavorable trends and outcomes
  • Bachelor’s Degree in a Healthcare related field and four (4) years of experience in a clinical discipline or Associate’s Degree in a Healthcare related field and six (6) years of experience in a clinical discipline or RN if less than at the Bachelor’s Degree level and six (6) years of experience in a clinical discipline
  • TX RN license if an RN
  • Certified Professional in Healthcare Risk Management (CPHRM) preferred

Clinical Configuration Specialist Resume Examples & Samples

  • Resolution of customer issues both remote and on site
  • Serve as field liaison with sales, marketing, and service organizations on customer-related product issues
  • Development and support of the physician clinical reports within the application
  • Participate in process improvement methodologies for training delivery
  • Support team and business Initiatives and comply with GE Policies
  • 100% compliance with GEHC implementation documentation requirements
  • Conduct on-site and remote clinical applications training to ensure the customer can effectively use the product to maximize their productivity
  • 5 years of clinical expertise focused primarily on diagnostic imaging
  • Background in digital diagnostic imaging workflow, including RIS and PACS
  • In depth knowledge of PACS implementation methodology and possesses the ability to translate this in support of a successful implementation
  • Highly knowledgeable of the Centricity PACS architecture and theory of operation
  • Excellent verbal and written communication skills, including the ability to effectively facilitate training/presentations
  • Ability and willingness to travel extensively 70% to 90%
  • Highly skilled in the utilization of Microsoft VISIO, Project and Office Professional components
  • Willingness to learn and support additional products within ITPS
  • Cardiology software knowledge / Experience
  • Bachelor’s degree in business administration/related field
  • In depth knowledge of GEHC IT products in the Radiology space
  • Effective organizational, assessment and planning skills
  • Strong interpersonal and team leadership skills

Clinical Study Director Resume Examples & Samples

  • Medical reference and medical expertise for operational strategy within the CSO for study registries he/she is allocated to
  • Medical consultant for projects to be proposed to the CSO
  • Medical contact for interaction with physicians responsible for the project or the study at the customer level
  • Support with his/her medical knowledge and background a study or a project from
  • Business negotiation with customers to final product delivery \(e.g. study completion or
  • Project report or publication\)
  • Conduct the feasibility for study/project with the feasibility manager and other team members \(especially Medical Advisors in CSUs\)
  • Prepare and/or organize and/or participate to Investigator’s Meetings, Steering Committees, Data Monitoring Committee meetings \(only “open” part of the DMC meetings\)
  • Prepare and/or approve any documents related to the study and requiring a medical expertise \(extended synopsis, protocol, medical training material for study monitoring team and for investigators\)
  • Provide medical training to study team, CSUs \(Medical Advisors, monitoring\) and investigators
  • Develop interaction with Medical Advisors in CSUs for the best knowledge of the study, compound protocol
  • Participate to Investigators meetings
  • Provide medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, experts
  • Participate to clinical trial team \(and cluster if any\) meetings
  • Accountable for the medical review of data done by the clinical trial team, the case by case review of safety events reported to GPE and coding of events and drugs
  • Provide appropriate medical input for patient recruitment and retention strategy
  • Support the CSUs and affiliates to develop network of KOLs and experts and to select National Coordinators or members of Study Committees
  • Prepare and provide key medical information to investigators and/experts in respect with communication policies \(e.g. study results, DMC advice\)
  • Feasibility results with feasibility managers
  • Project/Study deliverables with the Clinical Study Team
  • Operational strategy with Project Leader \(s\)
  • Get support from the Unit Management Office to get appropriate medical staff in CSUs and to determine appropriate study budget according to medical considerations
  • Collaborate to Adjudication Committee Review including prior patients’ data review as needed
  • Ensure high quality execution from a medical perspective with support of all functions &
  • Quality & Continuous Improvement group
  • Ensure appropriate documentation and investigations of safety cases with Global
  • Pharmacovigilance and Epidemiology \(GPE\)
  • Ensure high quality of coding with coding officers
  • Licensed United States Medical Doctor or an International medical graduate who has certification by the Educational Commission for Foreign Medical Graduates \(ECFMG\)
  • 2-3 or more years of Phase 2/3 Clinical Research / Drug Development experience in the pharmaceutical industry
  • Knowledge in ICH, GCP and local regulations
  • Fluent in English \(writing and speaking\)
  • Additional Clinical Research and/or Drug Development experience in other therapeutic areas, especially Cardiovascular and Metabolism
  • Provide oversight of a study to ensure progress according to study timelines
  • Strong interpersonal and communication skills (verbal and written)
  • Project Management skills
  • Strong verbal and written English skills
  • Must be able to interact effectively with a variety of internal and external teams
  • CTOM will consult with the DPE/PL to ensure study decisions are aligned on program timelines, strategy and budget

Clinical Trial Document Specialist Resume Examples & Samples

  • Accountability to study Project Managers, or equivalent, for assigned global eTMF responsibilities sponsored by a Core Bard Division or International Business Center
  • Establishment and maintenance of a quality-focused partnership, with proactive provisioning of crucial TMF quality support to the study team from start-up to close-out
  • Provide real-time, constructive feedback, education and best practice demonstrations to promote user adoption and build a knowledge and awareness of GCP, GDP and associated processes
  • Oversee and manage essential document collection, including the timely and risk-based review and maintenance of eTMF content
  • Apply an integrative approach to eTMF quality management through efficient and judicious use of Clinical Trial Management System (CTMS), Oracle Remote Data Capture (RDC) and J-Review
  • Ensure documents are scanned, imported, classified and QC reviewed within eTMF on a daily / on-going basis
  • Conduct and/or assist in periodic inspection readiness exercises, internal audits and regulatory authority inspections
  • Represent C.R. Bard in the TMF Reference Model Project Team, and become an active influence for medical device requirements on relevant initiatives and working groups
  • Assist in training internal and external team members on Bard’s TMF configuration(s) and eTMF process and procedures
  • BS / BA / BSN or equivalent 4-year degree, preferably in a related scientific field. Associate degrees and technical certifications will be considered with strong, relevant prior experience
  • Thorough working knowledge of clinical trial methodology relating to the monitoring of clinical trials, GCP, FDA, and / or country specific regulatory environment
  • 1-3+ years of demonstrable, global TMF ownership spanning multiple indications
  • Experience working with eTMF software platform(s)
  • Experience working with Clinical Trial Management System(s)
  • Experience working with EDC system(s)
  • High to expert proficiency in MS Office Suite of products
  • Excellent interpersonal, administrative, verbal & written communication skills
  • Ability to work independently, at times with minimal supervision
  • Strong working knowledge of clinical trial design, execution and analysis methodologies
  • Ability to influence positive results in the absence of formally delegated authority or line management
  • Strong time management and prioritization skills to provide high quality deliverables while supporting multiple concurrent projects
  • Strong organizational skills, detail oriented
  • Medical Devices
  • Veeva Vault eTMF, Investigator Portal, Study Start-Up, Registrations, Submissions, QMS and/or Quality Docs
  • BioClinica’s OnPoint CTMS

Clinical Project Operations Manager Resume Examples & Samples

  • Support study lead and line functions with the development of trial budget and financial strategy, and assist with securing approvals
  • Systematically estimate the life-time costs of all relevant studies and work with all stakeholders to ensure that this estimate is of high quality
  • Ensure budgeting systems are accurate regarding financial forecasts, expenditures, and internal resource planning
  • Identify issues and propose mitigating plans for facilitating decision making
  • Support the Clinical Project Management Group Leads in actively monitoring adherence to budgetary targets including management reporting with variance analysis, proposals for corrective measures and decision support
  • Provide financial training to Clinical Project Management and clinical trials team as required
  • Develop best practices for allocating and managing resources
  • Improves and enforces compliance with business and financial control processes
  • Ad hoc financial analysis to support CPM group leads and PLS Finance as required
  • Advanced degree or equivalent education/degree in life science/healthcare is required
  • Fluent English (oral and written)
  • 6+ years Clinical Operations experience with at least 4 years managerial experience in planning, executing, reporting and publishing clinical studies
  • Proven ability to work independently in a complex matrix environment (including remote)
  • Proven experience in managing clinical trial budget
  • Excellent communication, negotiation and problem solving skills
  • Strong customer oriented mindset and independence
  • Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory process-es, and global clinical development process

Clinical Project Operation Manager Resume Examples & Samples

  • Support study lead and line functions with the development of trial budget and financial strategy, and assist with securing approvals. Contribute to quarterly trial budget review meetings
  • Systematically estimate the life-time costs of all relevant studies. Contribute to the original phasing of life-time costs for the studies and subsequent updates. Work with all stakeholders to ensure that this estimate is of high quality
  • Ensure budgeting systems are accurate regarding financial forecasts, expenditures, and internal resource planning. Coordinate generation of consolidated latest estimates on current year budget vs. originally planned and model potential impact on future year budget planning
  • Challenge and track project(s) resource requirements, expenditures and revenue target
  • Identify issues and propose mitigating plans for facilitating decision making. Liaise with relevant line functions (e.g., PLS finance, Pricing, Clinical Project Management) regarding financial deviations and forecast
  • Provide financial training to Clinical Project Management and PLS staff as required
  • Develop best practices for allocating and managing resources. May participate in or lead cross-functional process improvement initiatives
  • Significant Clinical Operations experience with managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organisation
  • Proven experience in managing clinical trial budget. Ability to address budget review question and reconcile planning with actuals, be it with customers, service providers and PLS finance
  • Demonstrated presentation and diplomacy skills. Negotiation and conflict resolution skills

Clinical Trial Leader Resume Examples & Samples

  • Lead the clinical protocol development process in collaboration with the Clinical Program Leader (CPL): responsible author for clinical protocols, amendments and related documents; contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from internal review boards. Collaborate with the Medical Directors of the Novartis local organizations (CPOs) and investigators to ensure their feedback is adequately integrated into protocol
  • Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions
  • Investigator/site relationship management is vital; must develop effective working relationship with key investigators in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Contribute to trial-related advisory boards. Lead investigators meetings. Lead protocol training meetings and support CPOs in the conduct of regional meetings. Accountable for all internal clinical meetings related to the clinical trial(s)
  • Lead and matrix manage the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, and resource requirements; speaks up against unrealistic timelines. Energizes CTT to adhere to global performance and quality standards: chair CTT meetings, report study progress and issues with their resolution plan. Engages the input of line functions at the appropriate time. Leads trial level interactions with Global Monitoring Operations (GMO) and other relevant functions including Integrated Medical Safety and Drug Supply Management
  • In collaboration with the CPL lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations
  • Prepare and run dose escalation meetings with investigators. Coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic, imaging and biomarker data, to provide consolidated information for dose escalation meetings with investigators
  • Forecast trial resources needs (external costs): accountable for the development, management and tracking of trial budget working closely with CRO Management, with Clinical Trial Budget Managers and TCO Global Program Managers. Accountable for accuracy of trial information in all trial databases and tracking systems
  • Sits on Early Program Team (EPT) to contribute to program strategy
  • Ensure that program specific standards (e.g., CRFs, outsourcing specifications including imaging, biomarkers PK, data monitoring, validation plans and data transfer specifications) are applied to the clinical trial, where applicable
  • Develop clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties including central lab and imaging vendors; manage interface with external vendors in cooperation with the CRO Management Department as well as with the Assay Research Lab. This also includes the set-up, logistics, documentation and clinical supplies needed for the clinical trial(s)
  • For TCO trials led by a US-based clinical trial leader, function as local trial leader (LTL) for all US activities including working closely with US GMO for all study start-up activities including regulatory documents, budget, contract agreements and all activities pertaining to updates as dictated by amendments. As the LTL be the primary contact for US sites for clinical conduct of the trial
  • May participate in the on-boarding and mentoring of new TCO staff
  • Contribute to the implementation of best practices and standards for trial management, including sharing lessons learned
  • Collaborates with the Global CTL in the development of various components of the operational plan including country allocation, site identification and selection, recruitment, study closeout, outsourcing, investigational product management, data review, and budget that are consistent with standard process and guidelines, including contingencies and implement actions as needed
  • Accountable for all local (US) project timelines and deliverables. Evaluates and communicates the probability and impact of risk, develops quality and risk management plans for performance and ensures this is integrated into the overall plan for the monitoring management project deliverables in accordance with the project plan
  • Accountable for the quality of the clinical trial execution in partnership with management, CQA and other key stakeholders. Provide operational input into protocol development, study-related documents (including, but not limited to Site Management Oversight Plan, CRO Monitoring Plans, etc.) to ensure efficient and effective delivery of trial objectives
  • Actively participate in vendor selection process from Request for Proposal (RFP) through final contract
  • Prepare and provide input into materials for Investigator Meeting and Monitors Training Meeting, as well as plan and execute the coordination of US Investigator Meetings
  • Manage, oversee or participate in the preparation and/or review process of trial-specific documents (e.g., Protocol, Amendment, Clinical Study Report, etc.), and support the generation of trial-specific clinical documents
  • Establishes and maintains strong communication across the matrix and build successful relationships with key US stakeholders, Global stakeholders and external vendor personnel. Proactively provides status updates keeping stakeholders informed and up-to-date on trial deliverables
  • Participate in the development of trial specifications (including user acceptance testing) with vendors and appropriate line function input to ensure the capture of quality data as per protocol requirements
  • Active leadership to local project teams
  • Coordinate, facilitate, and maintain trial-level training focused for US Clinical Trial Managers (CTM) (blinded and unblinded, if applicable) and Clinical Trial Specialists (CTS) assigned to the trial
  • Consistently utilizes well-defined processes for documenting and organizing work within their trial team

Clinical Sciences Multi Resume Examples & Samples

  • Provide updates to regional and/or Global head and NIBR management as re-quired
  • Holds group specific responsibilities, which may include administrative duties, staffing/hiring, local considerations, local process improvements, use of new tech-nologies and innovation and other responsibilities as assigned
  • May act as a Lead Clinical Scientist for an assigned project with responsibility for providing or coordinating project level documentation, regular project updates and implementation of the NIBR portion of the Clinical Development Plan. May serve as a study lead depending on the workload and extent of a project. Deputizes for local study leads as required. 8. Contributes, as requested, in the identification, evaluation and appropriate training of new centers suitable for studies/patient populations
  • Assist in the recruitment and training of all new CS&I staff into their group. En-sures on-boarding and mentoring plans are in place prior to their start date to facili-tate rapid and successful integration into the team
  • Build a strong, diverse team, develop talent including potential successors, and contribute to a highly productive organization that balances operational efficiency and delivery with scientific insight and innovation
  • May function as a liaison to other Line Functions (e.g. Drug Metabolism & Pharma-cokinetics (DMPK), Biomarkers) ensuring relevant skills (e.g. PK, clinical imaging) are developed and maintained within the local group
  • Experience in multiple clinical indications and/or therapeutic areas preferred
  • Capable of clear written and verbal expression of ideas, an active/proactive communicator
  • Ability to interact with a wide range of people and build strong positive relationships and lead cross-functional initiatives

Clinical Performance Consultant Resume Examples & Samples

  • Work with Marketing, R&D, Implementation, and GCS leadership to ensure business and training strategy alignment
  • Work closely with GCS Education Services Managers and other team members to guide the development of clinical educational materials and review content for clinical accuracy
  • Maintain a high level of knowledge of Medical Systems products and stay informed about upcoming product releases
  • Assess clinical and workflow impact of new product releases and translate information into educational materials
  • Facilitate customer and employee clinical and product training in person or using web-conferencing technologies
  • Facilitate clinical workflow assessments and optimization engagements to enable customer product utilization
  • Facilitate customer engagement and communication initiatives; assist in determining business and/or customer needs by effectively conducting interviews and leveraging various tools and analytical methods; summarize findings in a coherent manner to develop and propose appropriate solutions
  • Support the development of presentations and reports in support of client enablement engagements and optimization services
  • Maintain communication with internal and external customers to ensure customer satisfaction and continuous program improvement
  • Act as a liaison with field employees supporting customer training activities to provide learning and performance support
  • Provide program and project management related to the strategic, logistic, and tactical aspects of customer-facing and employee clinical education programs
  • Create and manage communications, Sharepoint portals, forums, etc
  • Balance a heavy workload in a fast-paced environment, while working on multiple projects simultaneously. Set individual priorities in context with team priorities, to meet goals in the face of multiple demands
  • Be agile and flex with business strategy changes
  • Act as a key contributor in a complex environment
  • Education: Bachelor’s degree in Education, Clinical (Pharmacy, Nursing) or healthcare related field preferred
  • Clinical nursing or pharmacy experience with Pyxis Technologies dispensing products required
  • Clinical training, experience with performance consulting and developing clinical training programs, educational materials, documentation, manuals, and online tools desired
  • Ability to engage C-Suite level individuals
  • Presentation skills required
  • Industry experience with Medical Devices, HIT, product implementation and support in a global environment preferred. Knowledge of health care and delivery system operations, health care informatics, and healthcare terminology (e.g., care management). Understanding of operations in the Health Care industry and a strong acumen of business processes, including operations, delivery models and revenue models
  • Understanding of program evaluation life cycle, data analysis, and clinical best practices preferred
  • Good project management experience and effective organizational skills
  • Confident and results-driven; consultative orientation, strong people and process/project management capability
  • Ability to develop and deliver learning to a wide range of audiences and cultures
  • Ability to independently develop complex interventions and performance support solutions
  • Knowledge of training methodologies, adult learning requirements, needs assessment and evaluation
  • Outstanding communicator; an individual who possesses superior written/verbal communication skills, as well as the ability to present his/her views in a clear and compelling manner
  • Attention to detail while multi-tasking several complex deliverables across multiple groups, cultures and time zones
  • Adaptability; learns quickly and responds positively to complexity
  • Comfortable working in a changing environment
  • Team player with superior people skills
  • Willing to make the tough decisions and be held accountable
  • Ability to travel up to 30-40% of the time

Clinical Territory Manager Resume Examples & Samples

  • 3-5 years of clinical sales experience in the healthcare industry
  • Comprehensive clinical and technical knowledge including clinical papers. Asks skillful questions
  • Comprehensive knowledge of account planning, territory management and forecasting
  • Adoption of consultative selling strategies: excellence in planning, execution and evaluation of sales calls
  • Advanced negotiation skills: works to facilitate negotiations which involve other businesses (CVG)
  • Strong clinical and business relationships with customers
  • Advanced understanding of internal workings of hospital labs/ theatres / departments e.g. purchasing, consignment, clinics, patient & implant scheduling and key influencers
  • Computer literacy including sound knowledge of the MS Office suite of software
  • Proven evidence of Medtronic Traits
  • Bachelor degree/Tertiary qualifications in nursing, general science, business degree or similar. Post Grad qualifications highly regarded
  • IBRHE industry qualification
  • Coronary Care / ICU Catheter Lab experience highly regarded

Clinical Technical Service Specialist Resume Examples & Samples

  • Bachelor’s degree OR 4+ years’ experience in a health related field
  • Technical certification program in a health related field (RN, RT, biomed, ect.)
  • 2+ years of experience Biomedical or Clinical Engineer, certified electronics or certified medical field
  • 2+ years of call center experience within the medical or pharmaceutical industry providing clinical and technical support to customers
  • 4+ years of experience repairing, maintaining or operating medical equipment in the medical or pharmaceutical industry – Biomedical or Clinical Engineer
  • Proficient experience with Microsoft Word and Excel, (Pivot Tables, V-Lookups, Macros)
  • Ability to trouble shoot with customers while simultaneously data entering the information directly into the computer
  • Demonstrated ability to work in a team environment
  • Possesses computer skills with experience in Word and Excel
  • Ability to communicate effectively via verbal and written forms

Clinical Product Specialist Resume Examples & Samples

  • Experience in patient monitoring in a variety of care settings
  • OR experience highly preferred
  • Must be goal-directed, and results oriented, with internal motivation to achieve high-level results
  • Strong verbal and written communication; exceptional client interaction skills
  • Strong ability to create and deliver presentations, education plans, and evaluation plans that reflect the needs of the customer
  • Exceptional thoroughness, attention to detail, and follow-through
  • Understanding of the markets in which Respiratory & Monitoring Solutions competes
  • High energy, entrepreneurial, and self-motivated
  • In depth understanding of consumable adoption process
  • Experience developing educational tools
  • Proficient in MS Office, including Word, PowerPoint, and Excel

Clinical Outcome Specialist Resume Examples & Samples

  • Responsible for optimizing post-surgical outcomes through education and training of physicians, technicians, and surgical staff
  • Assisting surgeons and staff with IOL power verification
  • At least five years of experience as an Ophthalmic Technician, Optometrist, or Ophthalmologist with an emphasis in the area of cataract evaluation and surgery
  • At least three years of experience in an ophthalmic industry setting with an emphasis on clinical work related to cataract and/or corneal refractive surgery
  • Must be willing to travel 50% within territory to include some weekends

Clinical Accounts Manager Resume Examples & Samples

  • Collects, analyzes, interprets, displays and reports data of employer groups utilization experience
  • Functions as clinical liaison to sales team, consultants and employers, acts as a liaison to RFP unit
  • Develops and implements work plans for selected clinical account management employer groups
  • Creates presentations regarding employer utilization with recommendations to control or improve
  • Works with other stakeholders in program planning, implementation and monitoring of program or initiative outcomes
  • Leads and manages multiple complex initiatives that impact the utilization, quality or effectiveness of health care delivery and/or health care services provided to members
  • Provides an assessment of programs, initiatives and interventions to determine the effectiveness of activities and makes recommendations to improve outcomes
  • Develops and leads targeted activities to improve HEDIS, CAHPS, provider satisfaction and other identified performance measures
  • Completes project-related communication and other communications, including member/physician mailings, business plans, graphics, minutes and agendas
  • Monitors and analyzes outcomes to ensure goals, objectives, outcomes, accreditation and regulatory requirements are met
  • Participates in departmental evaluation, audit and improvement activities
  • Leads, facilitates or participates in relevant committees and work groups; makes presentations; prepares reports, data or other materials for presentation
  • Identifies areas of improvement within the company and works collaboratively with other departments to develop clinical and non-clinical performance improvement projects
  • Researches best practices, national and regional benchmarks, and industry standards
  • In collaboration with Disease Management and Care Management, monitors the effectiveness of the programs on health outcomes. Assesses and participates in the evaluation and revision of Care Management programs to optimize health outcomes
  • In collaboration with executive management, identifies areas of opportunity and/or provider education
  • Communicates with providers, members and community resources as necessary to support the planning, implementation and evaluation of initiatives
  • Performs audit activities as required, participates in establishment of corrective action as necessary
  • Active and valid and unrestricted Registered Nurse License for applicable State preferred
  • Three to five years managed care, UM and/or case management experience
  • Experience in compliance, accreditation, service or quality improvement
  • Complex project management experience
  • OR Any combination of academic education, professional training or work experience, which demonstrates the ability to perform the duties of the position
  • Ability to work in an innovative health care delivery system and a belief in the HMO philosophy of delivering managed health care is desirable
  • Demonstrates a high level of interpersonal, negotiating, and written communication skills
  • Ability to independently problem-solve and interact professionally with members, providers, and staff is necessary
  • Basic PC skills, preferably in a Windows environment, are necessary
  • Knowledge of CPT coding and ICD coding is required

Clinical Trials Document Control Resume Examples & Samples

  • AA/AS degree with courses in the scientific/regulatory field or equivalent related experience
  • Moderate experience in a clinical and/or medical environment that includes working with regulatory records
  • Strong knowledge of all applicable regulations and guidelines with respect to regulatory documents and familiarity with medical terminology
  • Strong verbal, written, and organizational skills with a team-oriented approach
  • Proficiency in Microsoft Office Suite and email

Clinical Trial Operations Principal Resume Examples & Samples

  • Accountable for execution and on-time delivery of planned DSS milestones for clinical technologies from start-up through close-out
  • Drive DSS study team operations and connect with cross-functional study teams to deliver trials and programs
  • Develop and sustain strong relationships between internal stakeholders, external vendors, cross-functional peers, and DSS senior management
  • Synchronize deliverables between DSS, offshore resources, and vendors to deliver outcomes as planned
  • Influential in setting the strategy for Data Sciences (DS)
  • Management of operations through metrics. Categories include, but are not limited to, data, systems, general operations, and milestones
  • Reports into the DS Therapeutic Area leader and has accountability for global study planning and execution
  • Responsible for program/compound-level timelines, while ensuring compliance and quality
  • Responsible for the oversight of risk mitigation/risk management and contingency plans at a program level for all DSS deliverables
  • Influence and participate in clinical strategy team; including but not limited to protocol development and clinical technologies
  • Set expectations with the DSS team, the clinical study team, DS vendors, TA, and other external teams regarding timelines, processes and general coordination of the program
  • Communicate with confidence and leadership with these groups for prioritizations, actions, and resolutions throughout the life of a program
  • Act as a point of escalation for internal and external issues
  • Lead clinical study team in the development of key clinical trial systems, study conduct and study close-out as related to DSS operational activities
  • Oversee all Data Sciences timelines and metrics for assigned clinical trials
  • Lead DSS-related cross-functional meetings with clinical teams, safety teams and physicians
  • Oversee all vendor contracts for assigned clinical trials including accountability for Statement of Work (SoW) and Change in Scope
  • Participate in DSS-related cross-functional meetings with stakeholders as appropriate
  • Ensure stakeholder confidence in the health of the study by leading meetings to effectively communicate expectations, progress, issues and resolution
  • Partner with Total Quality Management Lead to ensure highest quality of team deliverables
  • Participate in any FDA or other regulatory meetings regarding assigned clinical trials
  • Influence decisions and approaches through effective negotiation
  • Ensure quality assurance as a measure to achieve audit and database lock readiness for assigned clinical trials and programs
  • Accountable for any audit findings regarding process execution or data integrity for any assigned clinical trial
  • Mentor team members
  • Accountable for supporting and utilizing Data Sciences policies and procedures
  • Works directly with internal clinical lead and internal and external medical experts to optimize and implement clinical studies
  • Leads interaction and maintains strong oversight of CROs in all aspects of study implementation and any study changes
  • Joint responsibility with clinical lead for monitoring the implementation and progress of a clinical study
  • Develops and maintains relationships with external vendors
  • Collaborates with consultants and contractors to Research and Development
  • Supports the development and implementation of standard operating procedures and common work practices within the team
  • Clinical study team member: works closely with the Study Manager and Clinical Project Manager and is responsible for coordination, tracking, and management of logistics in support of clinical trials
  • Reviews clinical trial documentation including monitoring visit reports, monitoring plans, communication plans, timelines, etc
  • Responsible for set‐up, maintenance, reconciliation, and archiving of electronic and paper Trial Master Files along with internal working file
  • Coordinates TMF transfer with CROs
  • Interacts with CROs, vendors, investigators, monitors and other external partners to provide information and resolution for specific study requests and issues
  • Requires a BA/BS preferably in nursing, biology, biochemistry, or related areas. 1- 2 years of experience in clinical research operations preferred
  • Experience in running one or more clinical studies in the following therapy areas is desirable: anemia, chronic kidney disease, dialysis, and/or oncology
  • Ensures adherence to standard operating procedures, good clinical practice, and FDA regulations with strong understanding of inspection readiness
  • Fluent in Good Clinical Practice (GCP) and is able insure implementation within any clinical study
  • Excellent oral and written communication and presentation skills

Molecular Clinical Laboratory Scientists Resume Examples & Samples

  • Good laboratory practices
  • Knowledge of quality control practices and regulations
  • Laboratory experience with molecular biology techniques including DNA isolation, PCR, Sanger sequencing, Next Generation Sequencing is a plus

Clinical Solutions Specialist Resume Examples & Samples

  • Maintaining a strong understanding of Industry trends and applicable technology
  • Ability to work independently or in team setting; ability to adjust to changing priorities
  • 3-5+ years clinical research experience and 3+ years successful pharmaceutical/CRO/medical sales experience ideal; comparable combination of education and experience may be considered
  • Operations experience in clinical trials preferred
  • Thorough knowledge of medical and pharmaceutical industry, terminology and practices
  • Proven ability in presenting

Head Clinical R&D Poultry Resume Examples & Samples

  • Design, conduct, monitor and support vaccine research and development trials with external and internal partners for the development of poultry vaccines. Generate data which support decision making processes and/or lead to market authorization
  • Work in a project team and initiate/manage sub-teams
  • Support project team work/due diligence processes/ maintenance projects
  • Ensure compliance in the area of GxP and work safety
  • Actively support patent filing
  • Support infrastructural projects
  • Support regulatory submissions by providing documentation/dossier for area of expertise and/or initiate provision of documentation via sub-team
  • Designing, conducting, monitoring, reporting and evaluating preclinical and clinical studies for vaccine development in poultry according to GxP regulations
  • Ensuring compliance with all relevant legal requirements within own area of responsibility (e.g. animal welfare, biosafety, GxP)

Clinical Monitor Local Resume Examples & Samples

  • Resource management
  • To be involved in evaluation of CRA resource for assigned trial,
  • Prepare investigator and site profile and decide on site selection by supervision,
  • Responsible for IMP import, distribution, return and destruction per local regulation and BI requirement under oversight,
  • Ensure all required local study documents including the patient information and informed consent documents in local language as well as local protocol amendments and all documents in the ISF, in close cooperation and with input from the TCM, CRA team and all other involved functions,
  • Responsible for translation and reviews of trial medication labels in cooperation with local DRA or other internal review functions,
  • In charge of clinical trial related equipment imported or purchased in China OPU, and relevant distribution, return,
  • Work with CRO manager/Purchasing on CRO/Vendor selection and provide feedback on service received
  • Trial oversight, management and operational activities
  • Ensure timely study milestone delivery,
  • Responsible for preparation of the enrolment plan with support if needed,
  • Responsible for routine tracking of the enrolment plan vs actual enrolment,
  • Ensure timely cleaning and delivery of trial data and documents, supports the completion of the Clinical Trial Report (provision of appendices) with support if needed,
  • Update systems timely and ensure the completeness and accuracy, e.g. CTMS,
  • Ensure patient safety during the conduct of the trial by reviewing regional/local safety information
  • Understand BI Cost structures, especially the trail budget; Clearly distinguish the cost allocation between BI & Vendors,
  • Establish and monitor local budget aspects including investigator fee with support if needed,
  • Prepare budget specification and offer for assigned study,
  • Responsible for IMC review through closing working with medical controller; Familiar with Finance budgeting cycle and take actions according to the timeline,
  • Periodically tracking and control the actual spending and extra budget based on the most updated milestone; Ensure study budget is well tracked and controlled within defined deviation percentage
  • Understand updated Finance SOPs and the impacts on daily business
  • Quality management
  • Meet mandatory compliance requirements and standards including ICH-GCP, BI SOP/guideline and regulatory requirement,
  • Coordinate to ensure appropriate study specific and medical/scientific training and advice delivered to local team including CRAs, CRO and site staff,
  • Act as CAPA leader for Trial case,
  • Ensure appropriate escalation of issues related to trial conduct and procedures as well as adequate support of CAPA,
  • Develop Risk Management Plan under guidance from line manager & timely maintenance during the whole trial process,
  • Conduct co-monitoring per BI SOP/Guideline request,
  • Closely monitoring the clinical data including patient safety data to be reported timely, correctly
  • Provide leadership
  • Provide leadership in the oversight and management of investigational sites in partnership with other key stakeholders (e.g. CRAs), including correct handling of IMP, patient data and material (e.g., biological samples) with support if needed,
  • Lead local team including CRO for outsourced study or CRA/CTA to manage the trial in accordance to protocol, SOP, ICH-GCP and regulatory requirement through routine meeting and timely communication including e-mail, phone call and newsletters by supervision,
  • Close contact with the global trial team and support of global trial activities,
  • To participate in communication with cross function including DRA team, CDMA team, PV team and BDM team, etc

Manager of Clinical Trial Associates Resume Examples & Samples

  • Manages interactions between the CTA team members and internal and external partners
  • Manages a team that is responsible for managing aspects of site development for US sites related to the conduct of clinical trials
  • Maintains a strong connection with counterparts across sites to ensure standardization of processes and appropriate resouce allocations
  • Identifies and manages training and guidance for the CTA team in a proactive manner to ensure consistent efficiencies are identified
  • Manages team resources to ensure proper workload distribution
  • Manages the performance and development individually for the Clinical Trials Associates
  • Collaborates with the management counterparts across BMS sites to ensure alignment on communication and business processes
  • Escalates issues and opportunities to mangement as appropriate for higher level action or senior management consideration
  • Manages recruitment activities for new hires into the Clinical Trials Associate role
  • Enhances team performance by facilitating new hire orientation process
  • Experience managing a team in a matrix environment
  • Experience preferred in the health care field or related industry
  • Good Clinical Practice & clinical research knowledge
  • Demonstrated mastery in the use of project management applications
  • Leadership of continuous improvement efforts
  • Experience with external partner management
  • Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems preferred
  • Experience with leading complex project initiatives
  • Bachelors Degree plus 3-5 years clinical research experience
  • 1-3 years team management and/or supervisory experience
  • US military experience will be considered toward supervisory and industry experience requirements

Manager, Non-clinical Statistics Resume Examples & Samples

  • M. S. or Ph. D. in Statistics, Applied Mathematics, or Engineering majors with significant academic training in Statistics
  • Proficiency in major statistical software packages (e.g., SAS, R, MINITAB, and JMP)
  • A minimum of 3 years experience in pharmaceutical industry with technical knowledge in the following areas
  • Maintain TMFs for assigned studies
  • The Specialist will have at least 6 years’ direct experience with trial master files in the biopharmaceutical or pharmaceutical industries. The Senior Specialist will have 6+ years’ direct experience
  • Must possess excellent organizational skills, follow-through, and great attention to detail
  • Must be able to follow standard operating procedures and effectively triage when deviations from procedures occur
  • Excellent oral and written communication skills. Must be able to communicate effectively with members of other departments and with study-site personnel (physicians, study coordinators, nurses, etc.) as needed
  • Must be advanced with computer applications such as Word and Excel, and possess the ability to learn other applications with appropriate training

Director, Modelling & Simulation / Clinical Resume Examples & Samples

  • Support global head of Modelling & Simulation (M&S) in acting as a mentor and coach to team members in Japan
  • Support global head of M&S to manage/oversee outsourced work with collaborating CROs for M&S work
  • Support global head on M&S in providing expert support to others within Global Clinical Pharmacology/Translational Medicine and project teams with respect to the design and analyses of population PK (/PD) studies
  • Contribute to the development of appropriate internal procedures to manage M&S work within EPCS and oversee SOPs/SWPs related to population M&S
  • Generating, compiling and oversee M&S analysis plans and reports in accordance with departmental SOPs/SWPs and regulatory guidelines
  • Conducting PK and PK/PD data analysis, using both non-compartmental and population approaches
  • Interact actively with clinical, statistics and data management functions within CCLO and PCUs
  • Draft and/or review Investigator Brochures, IMPDs, relevant sections of submissions documents (CTDs) and other Regulatory documents
  • Prepare Population PK and PK/PD related responses to requesting regulatory agencies
  • Represent Eisai at major scientific and medical meetings
  • Keep up to date on best current practices and knowledge in the fields of M&S and population PK/PD by attending training courses, conferences and reading relevant literature
  • 5- years experience

Clinical Trial Mgmt-fde Resume Examples & Samples

  • Bachelor's Degree in a scientific or health-related field
  • Demonstrated ability to manage complex situations through problem-solving, critical thinking and navigating ambiguity
  • Prior clinical trial site-level experience
  • Understand TPO selection and qualification process
  • Review TPO bids and leverage Lilly’s external sourcing group to drive selection decisions
  • Create and manage work plan and budgets
  • Manage activities based on operations guides with strategic partners (functional sourcing relationships)
  • Understand the correlation between outsourced scope of work and the trial budget to evaluate and communicate the financial status
  • Effectively communicate and build positive relationships with sourcing partners and ensure timely resolution of issues
  • Monitor performance metrics with TPO to ensure quality delivery, make necessary adjustments and document TPO oversight

Clinical Data-fde Resume Examples & Samples

  • Provides single point of accountability and deliverable ownership for all aspects of clinical data management
  • Acts as a primary contact within the Data Sciences & Solutions organization for all data issues related to assigned trials
  • Applies specialized therapeutic knowledge and data management discipline knowledge to ensure database deliverables are consistent, accurate, adherent to the data strategy, and deliver the clinical, statistical, and business demands of the team
  • Bachelor’s degree in drug development in areas intersecting with clinical data management (e.g., clinical operations, statistics, information technology, health outcomes, etc.)

Clinical Data Leader Resume Examples & Samples

  • Provides the single point of requirements definition, strategy communication, and deliverable acceptance to the vendors executing delivery of clinical data management
  • Experience with one of the following
  • Vendor management experience
  • Virtual team environment experience
  • Familiarity with clinical data tools and technologies
  • Technical knowledge to develop requirements and/or study/project deliverables (i.e. SAS,Oracle, programming, analytical tools)
  • Experience in forms design and layout
  • Understanding and experience in using data standards

Clinical Trial Lead / Merck Serono Resume Examples & Samples

  • Works with substantial discretion and uses best practices and knowledge of internal or external business issues to improve products or services
  • Uses specialist knowledge, analytical skills, judgment and broad conceptual and practical experience to solve complex problems and to contribute to process improvements
  • Understands how the different teams jointly achieve the objectives of the area and uses knowledge of the organization, processes, customers and key business drivers to increase effectiveness
  • Drives protocol development process. Provides clinical, scientific and operational input into concept sheets and protocol (rational, objectives, design), Case Report Form, and other key protocol/program documents and activities
  • Leads the execution of clinical phases of assigned global programs across all phases (Phase 1-4) including post-marketing commitments and Biosimilars
  • Acts as a central point of contact for communication between the team and the external partners, developing mitigation and resolution strategies, and promptly responding to action items
  • Fluency in English (oral and written)
  • Position requires both domestic and international travel up to 30% of time

Principal Clinical Trial Lead Resume Examples & Samples

  • Implements, conducts or monitors on-site clinical trials
  • Takes responsibility for on-site operations of clinical trials, including documentation strategies, implementation of clinical trials protocols, standard operating procedures (SOPs) and case report forms (CRFs). May also help define or improve these but main emphasis will be on implementation. Conduct and be reponsible for clinical studies in one or more therapeutic areas
  • Leads own team of professional staff to identify and resolve technical, operational and organizational problems of medium complexity
  • Filters, prioritizes, analyzes and validates dynamic material from a diverse range of external and internal sources to respond to operational challenges
  • Applies understanding of how different areas jointly contribute to achieving objectives within the sub-function (i.e. a subset of a function, typically consisting of several areas with independent budgets) supported by good industry knowledge to achieve objectives
  • Be responsible for planning, coordinating, preparing and conducting as well as for the budget of clinical studies within assigned therapeutic area(s)
  • Steer all activities of the study-team and the contributions of further internal and external units
  • Acquire clinical/pre-clinical development strategies in the assigned therapeutic area in cooperation with the involved parties
  • Accountable to drive and monitor protocol related activities throughout the lifecycle of the project ensuring targets are met according to timelines, budget and quality expectations
  • As core member of the Clinical Operations Team and leader of the Clinical Trial Team, aligns clinical trial team with organizational goals and objectives of the Clinical Operations Team and/or Global Program Team
  • May in addition take leadership of the Clinical Operations Team
  • Leads multiple cross-functional trial teams through start-up activities including study/site budgets and contracts, global geographic deployment (country/site identification, feasibility, selection), and country/site protocol approvals (MOH, IRB/EC) to study conduct, analysis and reporting
  • Develops and leads the presentation on trial status to ICSC and other relevant committees for deviations from budget and timelines as needed, highlighting issues and risks
  • Qualifies operational feasibility and establishes and analyzes protocol-level budget and grants throughout the life cycle of the trial
  • Applies clinical and scientific knowledge to prioritize the clinical data review and cleaning
  • Drives oversight of CROs and vendor management at trial level according to the applicable partnership model
  • Acts as functional lead for process improvement initiatives
  • Understanding of trial feasibility elements
  • Understanding of regulatory requirements across countries
  • Requires substantial professional experience (approximately 8-10 years) in clinical research in CRO or a Pharmaceutical or Biotechnology Industry environment with at least five (5) years of them depth and/ or breadth of expertise in clinical trial management including managerial responsibility
  • Proven experience in all aspects of clinical trial planning and start up (including budget and resource planning), and in executing the complete range of clinical trial activities, from start up through final trial report
  • Proven track record of having successfully led one or more multinational trials
  • Solid leadership skills and influencing skills

Clinical Trials Monitor Resume Examples & Samples

  • Ensure the Sponsor-Investigator and study team adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures, including DFCI CTO Monitoring standards and guidelines
  • Adhere to the protocols’ Data Safety Monitoring Plans; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates
  • Monitor clinical trial progress through a combination of remote data review and on site monitoring visits. Some travel will be required
  • Verify that trial data entered on the Case Report Form is consistent with patient clinical notes and other source documentation (source data verification)
  • Independently coordinate upcoming and ongoing monitoring assignments while meeting expected timelines for completion of monitoring activities and submission of written monitoring reports
  • Assist in the development and writing of clinical trial monitoring plans
  • Provide recommendations and guidance to study specific monitoring teams and assist in audit readiness and preparation
  • Participate in regular monitoring team group meetings
  • Bachelor's degree in a field relevant to research compliance and 3+ years of progressively responsible clinical trials experience with 1+ years of monitoring experience. Experience in an academic institution is preferred, especially working in collaborative efforts with upper administrators, faculty and research staff as well as research support personnel. Must have expertise in research ethics and the responsible conduct of research

Clinical Document Improvement Specialist Lead-north State Region Resume Examples & Samples

  • *This will be an office position located at Mercy Medical Center Redding with travel to St. Elizabeth Community Hospital in Red Bluff, CA and Mercy Medical Center in Mounty Shasta. Travel is required between facilities, and may be required for meetings ***
  • Assists CDI Manager with chart audits, quality audit and KPI audits
  • Assists CDI staff training and orientation
  • Oversees and leads workflow for CDI staff
  • Assist CDI manager with projects or tasks as needed
  • Provides expert level leadership for overall improvement in clinical documentation by providing proficient level review and assessment, and effectively articulating recommendations for improvement, and the rational for the recommendations
  • Performs regular rounding with unit-based physicians
  • Ensures effective utilization of the Midas Clinical Documentation Improvement Focus Study, documenting all verbal, written, electronic clarification activity
  • 5+ years acute care hospital clinical RN experience OR Foreign Medical Graduate with CDI experience
  • A minimum of 2 years of experience in Clinical Documentation Improvement
  • Experience communicating & working closely with Physicians
  • CCDS, CCDP or CCS certification
  • Ability to lead projects with complex responsibilities and timelines

Clinical Pharmacologist Resume Examples & Samples

  • The position is responsible for efficient, innovative, and timely clinical PK, PK/PD, and/or population PK study design, analysis, interpretation, and reporting of clinical studies to support international regulatory submissions
  • Provide small and large molecule clinical pharmacology expertise/support in the preparation of regulatory submissions (e.g. IB, IND, NDA)
  • Performs pharmacokinetic analysis, interpretation, and reporting of data from clinical studies
  • Responsible for design, analysis and communication of data on clinical pharmacology studies
  • Develops and implements new clinical pharmacology studies that impact development programs
  • Effectively represents clinical pharmacology in cross-functional study-team settings
  • Works in close partnership with Quantitative Pharmacology, Bioanalytical Chemistry, Project Management, Clinical Research, Biostatistics and Clinical Trials Management functional areas to support clinical development programs
  • PharmD, PhD, with pharmacokinetic training, fellowship and/or postdoctoral experience and 2+ years of clinical pharmacology/pharmacokinetics
  • Strong understanding of clinical pharmacokinetic concepts is required
  • Training/experience in advanced pharmacokinetics, clinical pharmacology and/or pharmacy with clinical research, drug development is desirable
  • Understanding of drug development process to provide clinical pharmacology support for clinical development (Phase 1 to Phase 4) for investigational agents and/or marketed drugs
  • Hands-on experience in clinical trials management/study conduct and/or basic laboratory sciences is desirable
  • Must have established computer skills with detailed knowledge of PK programs and analysis software (e.g. WinNonlin), along with experience with scientific graphing and analysis software (Sigma plot, GraphPad, Instat, etc). Must have excellent written and verbal communication skills
  • Must have excellent interpersonal, written and verbal communication skills
  • Must have critical thinking skills and ability to make decisions
  • Demonstrate ability to work independently
  • Exhibit excellent written and verbal data presentation skills to enable contribution to internal/external teams, conference presentations and publications

Clinical Data Lead Resume Examples & Samples

  • To act as key point of contact for the sponsor and the study team on day to day study data issues, e CRF design, edit checks and other implemented documents
  • To take part in study kick off (internal and external) meeting with DMPM
  • To identify out of scope tasks and bring to the attention of DMPM and contract analyst
  • To develop an understanding of the revenue recognition and revenue forecasting process and assist the DMPM on a monthly basis
  • To lead the development of specifications, implementation and testing of the CRFs, edit checks and data review and oversight listings (DVS)
  • To lead the development of DMP and study specific procedures and assisting DMPM in development of project plan and timelines
  • To set up and maintain data management study files for inclusion in the Trail Master file and ensuring these are maintained in audit ready state
  • He/ She should possess excellent organizational and planning skills as well as a demonstrated aptitude or project management and ability to lead more than one project and prioritize accordingly
  • Working as a Team Lead/ Associate Data Lead
  • Experience of at least one of ICON preferred CDMS (Rave, Inform, Oracle Clinical, OCRDC)
  • Strong client relationship management skills, and the aptitude to develop this further

Clinical Molecular Geneticist Resume Examples & Samples

  • Strong understanding of genetics and genotype-phenotype relationships
  • Ability to analyze medical and scientific literature
  • Familiarity with statistical analyses
  • Familiarity with clinical applications of genetic information
  • Familiarity with professional and regulatory requirements of a clinical laboratory
  • Familiarity with informatics and bioinformatic approaches to analysis and management of large datasets, data mining
  • Familiarity in customer facing setting & excellent interpersonal skills
  • Excellent communication skills, professional and polished manners
  • Ability to effectively translate scientific concepts for a wide range of internal and external audiences
  • Ability to manage multiple projects and deliver in a time-sensitive manner
  • Works with multiple contract research organizations to communicate detailed timelines and ensure that performance expectations are met
  • Attends internal team and other meetings
  • Provides training as necessary at investigator meetings and other trial-specific meetings such as site initiation visits and monthly teleconferences
  • Travel 25% or more of the time

Senior Principal Clinical Pharmacologist Resume Examples & Samples

  • Responsible for supporting the line management in resourcing, recruitment, supervision, training and staff development in Clinical Pharmacology
  • Accountable and responsible for the Clinical Pharmacology support for the assigned projects (branded, generics, and other R&D programs)
  • Responsible for ensuring appropriate Clinical Pharmacology representation on drug/ dosage form development and clinical teams and provision of PK/PD expertise and leadership to a project
  • Provides recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc) to the Clinical and Development teams and in regulatory documentation such as labeling
  • Stays abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Clinical Practice and internal SOPs, regulations for specific projects to which assigned, in order to be a team resource of clinical pharmacology and therapeutics knowledge in terms of both medical background and clinical trial design
  • Acts as technical lead for specific development projects, particularly BA/BE, Phase I and Clinical Pharmacology centric studies
  • Manage and initiate external collaborations with leaders in clinical pharmacology and Key Opinion Leaders
  • Minimum of 10 years’ experience required, including at least 5 years relevant pharmaceutical or related industry experience in clinical pharmacology
  • Will consider 8 years’ experience with at least 2 years postdoctoral training in Clinical Pharmacology
  • Direct experience with clinical pharmacology summary documents required for NDA and MAA
  • Knowledge of FDA, EMA and ICH guidances and regulations applicable to Clinical Pharmacology
  • Comprehensive understanding of worldwide clinical regulatory requirements with working knowledge of drug development process with a proven record in drug development from IND through regulatory submission and commercialization. Prior direct interaction with regulatory agencies and advisory boards is required

Clinical SRM / Outsourcing Manager Resume Examples & Samples

  • Excellent knowledge of the clinical development and other science and technology development process and vendor management process (including best practices), along with the ability to bridge science and business, to oversee contracting of investigators and organizations supplying clinical and other science and technology related services and to develop with procurement contracting strategies
  • Experience developing a cross functional SRM program utilizing and developing Key Performance Metrics and Service Level Agreements
  • Demonstrated mastery of outsourcing/SRM including: category management skills, methodologies for measuring the value of outsourcing decisions (financial and qualitative), contract management, financial analysis, market analysis, supplier analysis,
  • Must have knowledge of cGCP, ICH, FDA, and other regulatory requirements
  • Supplier diversity and supplier relationship management
  • Expertise in internal stakeholder management, continuous improvement, and project management
  • Highly organized individual with the ability to set and manage multiple priorities to complete tasks within established and often, tight, timelines; work in a fast-paced matrix environment, interact well with all levels of the company, and work without direct supervision
  • Excellent interpersonal, oral and written communication skills
  • Strong analytical and problem solving skills with the proven ability to obtain results
  • Strong negotiation skills
  • Self-Starter
  • Proven business acumen
  • Display behaviors in accordance with Mallinckrodt Values
  • Strong computer skills; must be proficient in Microsoft Office (Word, Excel, PowerPoint), and SharePoint
  • Lean Six Sigma training/background preferred
  • Preferred background in financial modeling -Total Cost of Ownership(TCO) and Total Value of Ownership(TVO)
  • Membership in the International Association of Outsourcing Professionals (IAOP) and Certified Outsourcing Professional (COP) certification is highly desirable

Clinical Service Specialist Resume Examples & Samples

  • To teach prescribing physicians and key operators how to deliver a safe, effective and trouble-free THERAKOS® Photopheresis therapy to their patients
  • Troubleshoot and support via face to face activity and phone contact customers and Therakos field personnel
  • Transfer technical and clinical knowledge of the THERAKOS™ Photopheresis Systems to customers to ensure that they are capable of delivering safe and effective therapies to their patients
  • Certify trainees and manage the certificate process
  • Troubleshoot and support customers and Therakos field personnel (phone, email face to face meetings)
  • Release new software or kit modifications that require hands on training
  • Escalate market information, customer feedback and complaints, products performances and their use to the relevant departments
  • Handle the intake of customer complaints and associated activities with closing out those complaints in a timely and compliant manner
  • Attend local, regional and global commercial meetings
  • Build advocacy for existing and future Therakos products among national thought leaders of various target customers, including physicians, nurses, operators, hospital administrators and payers
  • Collaborate closely with Global Marketing and Scientific Affairs teams to develop product-positioning methods of communication for existing and future products and indications that will meet the needs of the current customer base and allow compliant expansion into to markets
  • Excellent English, German and French communication skills
  • Registered Nurse highly preferred
  • Advanced degree preferred in nursing or life science, pharmacy, medical technology, biomedical engineering or related field
  • Working experience in the medical device /pharma /healthcare industry such as clinical practice consultant, medical sales representative, customer technical support and clinical trainer
  • Knowledge or expertise in apheresis or immune mediated inflammatory diseases, haematology and oncology is a plus
  • Work permit and driver license for European Union

Related Job Titles

help with writing clinical experience and skills on resume

8 Nurse Practitioner Resume Examples + How to Write

help with writing clinical experience and skills on resume

This article, “8 best nurse practitioner resume examples + how to write + common blunders to avoid,” is a helpful document to provide you with the essential information to prepare an outstanding NP resume. Some of you may be seeking the best nurse practitioner resume examples? We present resume tips and examples for new grad NPs as well as those with experience. Learn the most effective techniques to write your NP resume without stress. We make this task easy for you. You no longer need to fret and put off creating an impressive resume. So, feel free to peruse our NP resume guide and get started on developing this essential document that is sure to wow any prospective employer.

WHAT EXACTLY IS THE PURPOSE OF A NURSE PRACTITIONER RESUME?

Is it necessary for all nurse practitioner job applicants to write a resume, 3 reasons why a well-written nurse practitioner resume makes a difference, 1. you increase your chances of getting an interview:, 2. a potential employer may find something unexpected that brings you to the forefront of applicants:, 3. the reader does not have to dig as much:, what are the essential parts of a nurse practitioner resume, 1. contact information:, 2. objective (or summary):.

• Your title of nurse practitioner and your specialty. • What job you are applying for. • Mention the employer by name (i.e., Harrisburg Hospital or St. Johns Family Practice Associates). • Use descriptive and enticing words to briefly describe some of your positive qualities and experience that may entice the reader, such as organized and enthusiastic. • You may include a goal if you are seeking a position that will further your career, such as “seeking an opportunity to hone my NP skills in pediatrics”.

3. Education:

4. licensure:, 5. experience:, 7. other areas to include:.

• Additional Experience (non-nursing) • Professional Memberships • Volunteerism • Awards and Accomplishments • Publications and Presentations

WHAT ARE THE BEST NEW GRAD NURSE PRACTITIONER RESUME EXAMPLES?

Example #1: new grad family nurse practitioner, example #2: doctorally prepared fnp without experience, example #3: psych np with a niche specialty, example #4: inexperienced pmhnp seeking a job in a long-term care facility, what are the best experienced-nurse practitioner resume examples, example #1: experienced fnp resume with exceptional accomplishments to boost resume, example #2: seasoned family nurse practitioner with a specialty area, example #3: psychiatric nurse practitioner resume for telehealth position, example #4: substance abuse pmhnp.

• Board Certified Family Nurse Practitioner, AANP, Pennsylvania and New Jersey, 2014-Current • Registered Nurse, New Jersey State Board of Nursing, 2003

• Achieved top-performing provider award • AANP Pennsylvania State Award of Excellence for Nurse Practitioners

HOW TO WRITE AN OUTSTANDING NURSE PRACTITIONER RESUME?

Step #1: gather the facts, about the step:, step #2: research the process, step #3: wow them with your objective statement., step #4: add your education., step #5: list your work experience., step #6: include your licensing information., step #7: add skills and any other pertinent headings., step #8: prepare a rough draft, step #9: individualize the resume to the job., step #10: proof it, bonus 6 common nurse practitioner resume blunders and how to fix them, blunder #1: too long (or short), about the blunder:, blunder #2: full of errors, blunder #3: keep it professional looking, blunder #4: not including all essential parts, blunder #5: boring, blunder #6: not individualizing it to the job, my final thoughts, frequently asked questions answered by our expert, 1. what is the difference between an np resume and np cv, 2. which format is best for a new grad np resume, 3. which format is best for an experienced np resume, 4. how long should a resume be for a new grad np, 5. how long should a resume be for an experienced np, 6. what is a good objective for a new grad np resume, 7. what is a good objective for an experienced np resume, 8. how to add nurse practitioner clinical experience to my new grad np resume, 9. how do i write my msn fnp credentials on my new grad np resume, 10. how do i write my dnp fnp credentials on my new grad np resume, 11. how many resumes should i bring to an np interview, 12. as an experienced np, how much work history looks good on my resume, 13. should i list rn license on my new grad nurse practitioner resume, 14. do i need a different resume for each np job i apply to, 15. how often should i update my np resume, 16. how much time does it take to create an outstanding np resume, 17. should i put my gpa on my new grad np resume, 18. should i include preceptorship on my experienced np resume, 19. can i use ready resume templates to create my np resume, 20. what useful online tools can be used to create an outstanding np resume.

help with writing clinical experience and skills on resume

Resume Worded   |  Proven Resume Examples

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Clinical Manager Resume Examples: Proven To Get You Hired In 2024

Hiring Manager for Clinical Manager Roles

Clinical Manager Resume Template

Download in google doc, word or pdf for free. designed to pass resume screening software in 2022., clinical manager resume sample.

Thinking of stepping into a Clinical Manager role? Well, it's a multi-faceted job that requires not just medical expertise, but solid management skills as well. The healthcare industry has seen a push for more efficiency and better patient care, and Clinical Managers play a crucial role in achieving these goals. As such, recruiters are on the lookout for those who can balance administrative tasks while ensuring top-notch medical service. When crafting your resume, it's important to demonstrate this balance clearly. Clinical Managers are now often expected to lead initiatives like electronic health record implementation or new healthcare regulations. This has made experience with project management and change leadership highly desirable. So, besides your clinical experience and skills, it's essential to showcase these aspects on your resume to stand out in today's market.

A well-prepared resume of a Clinical Manager featuring project management and regulatory compliance expertise.

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Recruiter Insight: Why this resume works in 2022

Tips to help you write your clinical manager resume in 2024,    show off your project management experience.

Clinical Managers are expected to lead major initiatives, so it's important to incorporate your project management experience on your resume. You should discuss specific projects you've managed, the teams involved, and the results achieved.

Show off your project management experience - Clinical Manager Resume

   Prove your proficiency in healthcare regulations

Given the rapidly changing landscape, compliance with healthcare regulations is crucial. Your resume should indicate your understanding of current healthcare laws, policies, and procedures. Mention any audit or compliance activities you've been involved in, and the outcomes.

Clinical Managers navigate the busy intersection of healthcare administration and patient care, often working behind the scenes to keep hospitals or clinics running smoothly. The demand for these professionals is on the rise, with changes in healthcare policy and an increasingly aging population requiring efficient management. When writing your resume, it’s crucial to convey your capability to handle the administrative side of healthcare, while not losing sight of patient satisfaction and staff morale. As a Clinical Manager, you're expected to wear many hats, so your resume must reflect your multifaceted skill set, from project management to your understanding of healthcare regulations.

Professional Clinical Manager resume with a focus on healthcare policy knowledge and evidence of improved patient care quality.

   Detail your understanding of healthcare policy

A Clinical Manager role often entails making decisions based on healthcare policy. Therefore, you should include any experience you have in interpreting healthcare policy changes and implementing policies in a clinical setting. This can illustrate your ability to navigate the complexities of the healthcare system effectively.

   Quantify your achievements in patient care quality

As a Clinical Manager, one of your key responsibilities is to manage and improve patient care quality. On your resume, go beyond simply listing this responsibility. Include metrics or quantifiable evidence of how your management improved patient care quality or increased patient satisfaction during your previous roles.

Quantify your achievements in patient care quality - Clinical Manager Resume

  • Clinical Manager Resume Tips

As a hiring manager who has recruited clinical managers at top healthcare companies like Mayo Clinic, Cleveland Clinic, and Johns Hopkins Medicine, I've seen countless resumes for this role. In this section, I'll share insider tips on how to make your clinical manager resume stand out and increase your chances of getting hired.

   Highlight your clinical expertise

Employers want to see that you have the necessary clinical skills and knowledge to manage a healthcare team effectively. Be sure to:

  • Mention your clinical certifications, such as RN, NP, or PA
  • Describe your experience in patient care, such as 'Managed a caseload of 50+ patients in a fast-paced hospital setting'
  • Highlight any specialized clinical skills, like 'Proficient in conducting physical assessments and developing treatment plans'

Avoid simply listing your clinical skills without context, like this:

  • Clinical skills: patient care, assessments, treatment plans

   Showcase your leadership and management abilities

Clinical managers are responsible for leading and supervising healthcare teams. Demonstrate your leadership experience by including examples like:

  • Supervised a team of 15 nurses and medical assistants, resulting in a 20% increase in patient satisfaction scores
  • Implemented a new scheduling system that reduced staff overtime by 30%
  • Collaborated with physicians and administrators to develop and execute quality improvement initiatives

Don't just state that you have leadership skills without providing evidence, such as:

Skilled leader with experience managing healthcare teams.

   Quantify your accomplishments with metrics

Using numbers and metrics to quantify your achievements makes your resume more impactful and credible. For example:

  • Reduced patient wait times by 25% by implementing a new triage system
  • Managed a $500K annual budget and consistently met financial targets
  • Improved staff retention rates by 15% through implementing a mentorship program

Avoid using vague statements that lack specific details, like:

  • Improved patient wait times
  • Managed department budget
  • Increased staff retention

   Tailor your resume to the specific job posting

Customize your resume to align with the requirements and preferences outlined in the job description. For instance:

  • If the job emphasizes experience with a particular electronic health record (EHR) system, highlight your proficiency with that specific EHR
  • If the position requires a certain number of years of management experience, make sure to clearly state the duration of your relevant roles

Generic resumes that fail to address the specific needs of the employer are less likely to capture their attention, such as:

Experienced clinical manager seeking a challenging new role in healthcare.

   Include relevant education and professional development

In addition to your nursing or medical degree, showcase any advanced degrees, such as an MSN or MBA, that are relevant to the clinical manager role. Also, highlight any recent continuing education or professional development courses you've completed, like:

  • Completed a leadership development program focused on healthcare management best practices
  • Earned a certificate in healthcare quality and safety from the Institute for Healthcare Improvement

However, avoid listing irrelevant or outdated education or training, such as:

  • Completed a CPR certification course in 2005
  • Attended a conference on medical billing and coding (if not directly related to the clinical manager role)

   Demonstrate your commitment to patient safety and quality

Clinical managers play a crucial role in ensuring patient safety and quality of care. Showcase your dedication to these areas by including examples like:

  • Developed and implemented a fall prevention protocol that reduced patient falls by 30%
  • Led a team that achieved a 95% compliance rate with hand hygiene guidelines
  • Collaborated with quality improvement specialists to identify and address areas for improvement in patient care

Don't simply claim to be committed to patient safety and quality without providing concrete examples, such as:

Passionate about delivering high-quality, safe patient care.

Skills For Clinical Manager Resumes

Here are examples of popular skills from Clinical Manager job descriptions that you can include on your resume.

  • Mental Health
  • Healthcare Information Technology (HIT)
  • Patient Education
  • Standard Operating Procedure (SOP)
  • Basic Life Support (BLS)
  • Advanced Cardiac Life Support (ACLS)
  • Nursing Management
  • Good Clinical Practice (GCP)

Skills Word Cloud For Clinical Manager Resumes

This word cloud highlights the important keywords that appear on Clinical Manager job descriptions and resumes. The bigger the word, the more frequently it appears on job postings, and the more likely you should include it in your resume.

Top Clinical Manager Skills and Keywords to Include On Your Resume

How to use these skills?

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Clinical Research

A well-structured resume for a Clinical Trial Manager showcasing relevant qualifications and technological proficiency.

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Resume Guide: Detailed Insights From Recruiters

  • Clinical Research Resume Guide & Examples for 2022

Improve your Clinical Manager resume, instantly.

Use our free resume checker to get expert feedback on your resume. You will:

•  Get a resume score compared to other Clinical Manager resumes in your industry.

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Clinical Manager Resumes

  • Template #1: Clinical Manager
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  • Clinical Manager Interview Guide
  • Clinical Manager Sample Cover Letters
  • Clinical Research - 2024 Resume Guide
  • Alternative Careers to a Clinical Manager
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  • Resume Action Verbs

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help with writing clinical experience and skills on resume

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help with writing clinical experience and skills on resume

I had a clear uptick in responses after using your template. I got many compliments on it from senior hiring staff, and my resume scored way higher when I ran it through ATS resume scanners because it was more readable. Thank you!

help with writing clinical experience and skills on resume

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help with writing clinical experience and skills on resume

  • • Oversaw scheduling of patients in alignment with protocol, enhancing patient turnover by 25%.
  • • Successfully educated and supervised coordinators, elevating team efficacy by 30%.
  • • Actively participated in investigator meetings, fostering an open environment for communication and brainstorming.
  • • Contributed to the design and implementation of clinical trials, advancing drug development process.
  • • Created detailed reports on patient progress and updated principle investigators, leading to timely decision-making.
  • • Ensured secure and ordered maintenance of investigative products, reducing inventory misplacements by 60%.
  • • Led patient recruitment for study randomizations, increasing the participant count by 40%.
  • • Liaised with the IRB, ensuring prompt and accurate protocol submissions.
  • • Managed special projects for Operations Team, contributing to overall operational efficiency.

5 Clinical Research Assistant Resume Examples & Guide for 2024

Customize this resume with ease using our seamless online resume builder.

All resume examples in this guide

help with writing clinical experience and skills on resume

Resume Guide

Demystifying the clinical research assistant resume format, optimizing the experience section of your clinical research assistant resume, decoding the essence of your clinical research assistant resume: hard and soft skills, choosing the right certifications and education for your clinical research assistant resume, summary or objective: making your clinical research assistant resume shine, additional sections to elevate your clinical research assistant resume, key takeaways.

Clinical Research Assistant resume example

Clinical Research Assistants often struggle with effectively communicating their diverse skill set, which includes both scientific knowledge and administrative capabilities. Our guide can assist by providing tailored advice on how to succinctly frame these skills in a resume, helping candidates highlight their unique blend of expertise in both scientific research and project management.

Here's what you'll read within our professional resume guide:

  • Clinical research assistant resumes that are tailored to the role are more likely to catch recruiters' attention.
  • Most sought-out clinical research assistant skills that should make your resume.
  • Styling the layout of your professional resume: take a page from clinical research assistant resume examples.
  • How to write about your clinical research assistant achievements in various resume sections (e.g. summary, experience, and education).

Recommended reads:

  • Quantitative Researcher resume
  • Graduate Research Assistant resume
  • Undergraduate Research Assistant resume
  • Student Researcher resume
  • Security Dispatcher resume

While a touch of creativity can be appealing, it's the clarity and relevance of your clinical research assistant resume format that truly resonates with recruiters.

To ensure your resume not only captures attention but also maintains it, consider these four streamlined steps:

  • If your career boasts a wealth of pertinent and recent accomplishments, the reverse-chronological resume format is your ally. It naturally emphasizes your experience, placing your most recent roles at the forefront.
  • Design a straightforward header: incorporate your contact information, a headline reflecting the position you're vying for or your current designation, and a link to your professional portfolio.
  • While brevity is key, if you're targeting a senior position or have accumulated over ten years of industry-relevant experience, extending your resume to two pages is permissible.
  • To ensure consistent formatting across various platforms, always save and submit your clinical research assistant resume as a PDF.

Upload your resume

Drop your resume here or choose a file . PDF & DOCX only. Max 2MB file size.

  • functional skill-based resume format - that puts the main focus on your skills and accomplishments;
  • hybrid resume format - to get the best of both worlds with your clinical research assistant experience and skills.

Essential sections for a standout clinical research assistant resume:

  • The top section should combine your header—with accurate contact details—and a concise summary or objective that encapsulates your professional achievements.
  • An experience section that chronicles your career trajectory and how each role contributed to your professional development.
  • Highlight significant achievements that demonstrate the practical application of your skills, leading to tangible results.
  • Include industry-recognized certifications to underscore your technical proficiency or interpersonal skills.
  • Detail your educational background relevant to the field.

What recruiters want to see on your resume:

  • Clinical Research Experience: Recruiters look for prior experience in clinical research, including knowledge of clinical trial procedures, data collection and analysis, etc.
  • Knowledge of Regulatory Standards: Familiarity with FDA regulations, GCP guidelines, and other relevant compliance requirements is highly valued.
  • Technical Skills: Proficiency in data management software (like EDC systems), MS Office Suite, and statistical analysis tools can be a strong asset.
  • Detail-Oriented: Ability to pay attention to details and ensure accurate and reliable results is crucial in this role.
  • Communication Skills: The ability to communicate effectively with multiple stakeholders, including patients, physicians, and research teams, is important for a Clinical Research Assistant.
  • The 23 Most Creative Resume Designs We've Seen
  • Resume Font

The experience section is pivotal—it bridges the gap between your qualifications and the job's requirements.

To craft an impactful clinical research assistant experience section, consider these guidelines:

  • Review the job posting to identify key requirements and align your past roles with these needs.
  • Go beyond listing skills—demonstrate their impact through quantifiable achievements.
  • Exclude roles that don't enhance your application or showcase relevant skills.
  • While technical expertise is crucial, also highlight soft skills that add value to your role.
  • Use action verbs to articulate your accomplishments and the skills employed to achieve them.

Below, we've provided clinical research assistant resume samples to inspire your experience section, ensuring it adheres to industry best practices.

  • Assisted in the coordination and execution of clinical research trials, ensuring adherence to protocols and regulatory guidelines.
  • Managed data collection and analysis for multiple research studies, resulting in accurate and timely completion of study milestones.
  • Conducted participant recruitment, screening, and informed consent processes, maintaining a high enrollment rate throughout the studies.
  • Collaborated with interdisciplinary teams to develop and implement research protocols, contributing to the successful completion of projects.
  • Maintained detailed and organized study documentation, including case report forms and study databases, ensuring compliance with regulatory standards.
  • Performed literature reviews and background research to support the development of research proposals and protocols.
  • Collected and managed biological samples from study participants, following strict standard operating procedures.
  • Assisted in the creation and maintenance of study budgets, ensuring efficient allocation of resources.
  • Coordinated study visits and scheduled appointments with study participants, optimizing workflow and minimizing scheduling conflicts.
  • Contributed to the preparation of research publications and presentations, summarizing study findings and outcomes.
  • Supported the development and implementation of electronic data capture systems for clinical research studies, streamlining data management processes.
  • Conducted quality control checks on study data, ensuring accuracy and completeness of collected information.
  • Assisted in the preparation and submission of regulatory documents to obtain ethical approvals for research projects.
  • Coordinated with external vendors and suppliers to procure study materials and equipment, ensuring timely delivery and cost-effectiveness.
  • Provided training and guidance to new clinical research staff, facilitating their seamless integration into ongoing projects.
  • Conducted participant interviews and administered surveys to gather qualitative and quantitative data for research studies.
  • Performed statistical analysis using software such as SPSS, generating meaningful insights and contributing to data-driven decision-making.
  • Collaborated with principal investigators in the design and execution of clinical trial protocols, ensuring scientific rigor and integrity.
  • Managed study databases and maintained data confidentiality, adhering to privacy regulations and institutional policies.
  • Assisted in the preparation and review of study protocols and informed consent forms, ensuring compliance with regulatory requirements.
  • Supported the coordination and monitoring of multi-center clinical trials, ensuring site adherence to study protocols and regulatory standards.
  • Conducted site visits and audits to assess data quality, protocol compliance, and participant safety across multiple research sites.
  • Developed and delivered training programs for study personnel on Good Clinical Practice (GCP) guidelines and study-specific procedures.
  • Managed study documentation, including investigator site files and essential documents, maintaining audit-readiness at all times.
  • Contributed to the development of standard operating procedures (SOPs) for various aspects of clinical research operations.
  • Conducted literature searches and compiled relevant scientific articles to support the development of research proposals.
  • Coordinated participant recruitment efforts, resulting in high enrollment rates and timely completion of study milestones.
  • Assisted in the preparation and submission of grant applications, securing funding for research projects.
  • Managed study databases and performed data cleaning and validation procedures, ensuring data integrity.
  • Contributed to the writing and editing of research manuscripts and reports, summarizing study outcomes and implications.
  • Conducting literature reviews and critically analyzing scientific publications to identify potential research gaps and areas of investigation.
  • Assisting in the design and implementation of clinical research studies, including protocol development and study site selection.
  • Collecting, managing, and analyzing clinical trial data using electronic data capture systems and statistical software.
  • Contributing to the preparation of study reports and regulatory submissions, ensuring compliance with applicable guidelines.
  • Participating in multidisciplinary team meetings and providing regular updates on study progress and challenges.
  • Assisted in the recruitment and screening of study participants, ensuring their eligibility and informed consent.
  • Managed study-related documents, such as protocols, informed consent forms, and ethics committee submissions.
  • Conducted data entry, cleaning, and validation procedures, maintaining high data accuracy and completeness.
  • Contributed to the development of study-specific monitoring plans and performed site visits to ensure protocol compliance and participant safety.
  • Supported the coordination of investigator meetings and study training sessions, facilitating effective communication among study team members.
  • Performed clinical trial feasibility assessments, evaluating site capabilities and potential challenges for study implementation.
  • Assisted in the preparation and submission of study protocols and amendments to regulatory authorities and ethics committees.
  • Coordinated with clinical sites to obtain necessary approvals and maintain study documentation, ensuring compliance with regulations.
  • Conducted source data verification and monitored participant enrollment and retention rates, identifying corrective actions as needed.
  • Collaborated with external vendors and contract research organizations (CROs) to support study activities and meet project timelines.
  • Provided administrative support to clinical research teams, managing calendars, travel arrangements, and meeting logistics.
  • Assisted in the preparation and distribution of study materials, including informed consent forms and study questionnaires.
  • Maintained accurate and up-to-date investigator files and study binders, ensuring easy access to essential study documents.
  • Coordinated the shipment and tracking of investigational products and study supplies to various trial sites.
  • Assisted in the preparation of progress reports and study-related presentations, summarizing project status and outcomes.

Quantifying impact on your resume

  • Include the number of clinical trials you've managed or assisted with to demonstrate your experience in the domain.
  • Detail any quantifiable improvements made to data collection processes, such as reducing time taken or increasing accuracy, to show your impact and efficiency.
  • List the size of teams you've worked within or led, portraying your ability to work collaboratively or lead effectively.
  • Specify the number of patient records you've managed or processed, illustrating your capacity for handling large datasets.
  • Mention the volume of reports you've written or contributed to, showing your communication and documentation skills.
  • Highlight the number of regulatory compliance audits you've successfully passed to reveal your attention to detail and commitment to guidelines.
  • Provide numbers on training sessions conducted or attended to exhibit your dedication to continuous learning and teaching.
  • Quantify any cost-saving initiatives you were involved in to demonstrate your understanding of business constraints.

Tips for clinical research assistant newcomers launching their careers

Lacking extensive experience for that clinical research assistant role? No worries.

Sometimes, hiring managers go for the unexpected candidate when they see potential.

Here's how to convince them you're the right fit:

  • Opt for the functional skill-based or hybrid formats to highlight your unique professional value.
  • Always tailor your clinical research assistant resume to emphasize the most critical requirements, usually listed at the top of the job ad.
  • Compensate for limited experience with other relevant sections like achievements, projects, and research.
  • In your clinical research assistant resume objective, pinpoint both your achievements and how you envision your role in the position.
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  • Targeted Resume

The wording of your experience items should be with active, power verbs, instead of adjectives. Always be specific about each item you detail, and never overuse vague buzzwords. You weren't just "organized", but rather "Enhanced internal work processes to optimize operational management by 65%".

Every job description communicates the desired hard and soft skills. These skills are the backbone of your application.

Hard skills are your tangible, technical proficiencies, often validated through certifications or hands-on experience. On the other hand, soft skills reflect your interpersonal abilities and how you navigate diverse work environments.

To effectively spotlight these skills on your resume:

  • Create a distinct section for technical skills, listing the most relevant ones for the job.
  • Highlight your strengths by weaving in achievements that underscore specific skills.
  • Strike a balance between hard and soft skills to present a well-rounded profile.
  • If multilingual, include a language proficiency section, emphasizing the interpersonal advantages it brings.

Stay tuned for a deep dive into the most in-demand hard and soft skills in the industry.

Top skills for your clinical research assistant resume

Clinical research knowledge

Medical terminology

Data management

Bio-statistical analysis

Research protocol understanding

Patient recruitment strategies

Microsoft Office Suite proficiency

Regulatory compliance (FDA, ICH-GCP)

Electronic medical records (EMR) software

Phlebotomy or other laboratory skills

Communication

Attention to detail

Organizational skills

Problem-solving

Critical thinking

Teamwork/collaboration

Adaptability

Ethical judgment

Time management

The placement of your skills section should align with its importance. If it's a showcase of your most significant strengths, position it prominently near the top of your resume.

Your education section can highlight skills and experiences perfect for the job.

  • List college or university degrees with the school name and dates.
  • If you're still studying, mention your expected graduation date.
  • Think twice before adding unrelated degrees. Space on your resume is precious.
  • Discuss educational achievements if they boost your job relevance.

There are many certifications out there. Which ones should you include?

  • List your main degree in a separate section with the school name and dates.
  • Only add certifications that highlight your skills and experience.
  • Place unique or recent certifications near the top.
  • Add a brief description to certifications if it helps show your skills.

Remember, it's not about quantity but relevance.

Best certifications to list on your resume

If a particular certification is highly valued in the industry or by the company, consider highlighting it in your resume's headline.

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Start your resume with a strong summary or objective to grab the recruiter's attention.

  • Use a resume objective if you're newer to the field. Share your career dreams and strengths.
  • Opt for a resume summary if you have more experience. Highlight up to five of your top achievements.

Tailor your summary or objective for each job. Think about what the recruiter wants to see.

Resume summary and objective examples for a clinical research assistant resume

  • Accomplished Clinical Research Assistant with over 5 years of experience in managing complex clinical trials in a fast-paced environment. Possessing exceptional data analysis proficiency, I've successfully streamlined operational processes to enhance efficiency. Renowned for my detail-orientation, I have consistently maintained study compliance and integrity.
  • Dedicated healthcare professional making the transition into clinical research. With a successful 10-year background as a Registered Nurse, I bring a profound understanding of patient care, health protocol adherence, and medical terminology. Familiar with medical software, and committed to advancing knowledge in clinical protocols to drive improvements in research quality.
  • Eager to contribute my strong organizational abilities and attention to detail towards a career in clinical research. Having recently graduated with a Master's in Public Health, I am well versed in epidemiology and biostatistics. Committed to using my academic knowledge to effectively assist in clinical trials and research studies.
  • Experienced Project Manager transitioning to the field of clinical research. With a track record of coordinating large-scale projects and a PMP certification, I offer robust planning and execution skills. Looking forward to applying my knowledge of Six Sigma methodologies to improve efficiencies in clinical trial management.
  • Bringing forth a Bachelor’s degree in Life Sciences and an inherent passion for scientific discovery, I am seeking to channel my analytical skills and theoretical knowledge into practical applications within a clinical research setting. Interested in contributing to life-changing studies and creating a positive impact on patient lives through diligent and ethical research practices.
  • As a recent graduate in Biomedical Science, I seek to leverage my solid foundation in laboratory techniques, data collection, and statistical analysis towards a progressive career in clinical research. An enthusiastic learner, I aspire to facilitate compelling research that contributes to advancements in patient care and treatment strategies.

To further differentiate your clinical research assistant application, consider adding sections like:

  • Publications
  • Hobbies (only if they align with the job or showcase relevant skills).

These sections can further demonstrate your technical acumen and interpersonal skills.

  • Craft a clinical research assistant resume that's easy to read and aligns with the role's requirements.
  • The top third of your resume should clearly convey your unique value proposition for the clinical research assistant role.
  • Tailor your resume to the job, highlighting skills, achievements, and the tangible results of your efforts.
  • Detail your certifications and technical skills to demonstrate proficiency with specific tools and technologies.
  • The sections you choose should collectively present a comprehensive view of your professional expertise and personality.

clinical research assistant resume example

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Top 16 Clinical Researcher Resume Objective Examples

Photo of Brenna Goyette

Updated July 12, 2023 14 min read

A resume objective is a concise statement that outlines your professional goals and how they align with the job you are applying for. As a clinical researcher, your objective should demonstrate your knowledge and experience in the field, as well as provide evidence of your ability to effectively contribute to the organization. When writing a resume objective for this position, focus on your skills related to conducting research and collecting data. Additionally, emphasize any expertise you have in analyzing results or creating reports. For example, “Dedicated clinical researcher with 5 years of experience managing studies and analyzing data. Seeking to leverage my advanced data analysis skills and research acumen to support ABC Organization’s mission.” This statement shows that the applicant has relevant experience, specialized skill sets, and a clear understanding of what is expected from them at the job.

Clinical Researcher Resume Example

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Top 16 Clinical Researcher Resume Objective Samples

  • To secure a challenging position as a Clinical Researcher in an organization that will utilize my experience and knowledge to the fullest.
  • To obtain a Clinical Research position with a reputable organization where I can use my skills and experience to help further the company’s goals.
  • Seeking a Clinical Research role that allows me to contribute to the success of the organization while utilizing my expertise in clinical research.
  • To work as a Clinical Researcher in an environment that encourages creativity, professional growth, and team collaboration.
  • Seeking an opportunity as a Clinical Researcher with an established organization that values hard work and dedication.
  • To join an innovative team of professionals as a Clinical Researcher where I can apply my knowledge and skills towards achieving organizational objectives.
  • Looking for a position as a Clinical Researcher to utilize my extensive experience in clinical research and data analysis.
  • Aiming for a position as a Clinical Researcher at XYZ Company where I can make use of my strong background in medical research.
  • Seeking an opportunity to work as part of the clinical research team at ABC Company, utilizing my knowledge and experience in clinical research.
  • Applying for the position of Clinical Researcher at XYZ Company, bringing strong technical skills, excellent communication abilities, and creative problem-solving abilities to the role.
  • Desire to join ABC Company as a Clinical Researcher where I can make use of my excellent analytical and communication skills while helping develop new treatments for patients.
  • Passionate about working with ABC Company as a Clinical Researcher where I can bring my expertise in medical research and data analysis to help advance patient care initiatives.
  • Interested in applying for the role of Clinical Researcher at XYZ Company, offering strong attention to detail, excellent organizational skills, and enthusiasm for learning new technologies related to medical research.
  • Aiming for the position of Clinical Researcher at ABC Company which will allow me to contribute towards developing effective treatments through evidence-based medical practices while utilizing my extensive knowledge in clinical research principles.
  • Seeking employment with XYZ Company as a Clinical Researcher where I can leverage my expertise in data collection methods, statistical analysis techniques, and medical terminology to support patient care initiatives.
  • Eagerly looking for an opportunity with ABC Company as a Clinical Researcher which will allow me to combine my passion for medicine with cutting-edge technology while contributing towards advancing patient care initiatives within the organization

How to Write a Clinical Researcher Resume Objective

A clinical researcher resume objective is a short and succinct statement that outlines your professional goals. It should be tailored to the specific job you are applying for and should demonstrate your knowledge, skills, and experience in the field of clinical research. Writing a strong resume objective can help you stand out from other applicants and make it easier for employers to see why you are the ideal candidate for the position.

When writing a clinical researcher resume objective, begin by clearly stating what position you are applying for and why you believe you would be an excellent fit. Make sure to include any relevant experience or certifications that may be beneficial to the role. For example, if you have worked as a clinical research assistant before, mention this so employers know what kind of expertise you have in the field. Additionally, highlight any special skills or qualifications that set you apart from other applicants such as proficiency with medical software or laboratory techniques.

Next, explain how your past experiences have prepared you for success in this new role. For instance, if you have been working as a research assistant since completing your degree, discuss how this has enabled you to develop important analytical and organizational skills which could be beneficial in a research position. Also consider mentioning any awards or extracurricular activities which demonstrate your commitment to advancing your career in clinical research.

Finally, end your resume objective with a statement about what makes you passionate about this particular job or field of work. This will show employers that not only do you possess the required qualifications but also an enthusiasm for the role which could give them further confidence in hiring you.

By following these steps when writing a clinical researcher resume objective, employers will be able to quickly assess why they should consider hiring you and how your skills can benefit their organization.

Related : What does a Clinical Researcher do?

Key Skills to Highlight in Your Clinical Researcher Resume Objective

In the highly specialized field of clinical research, certain skills and competencies are crucial for success. These skills not only aid in performing daily tasks but also contribute to long-term career advancement. When crafting your resume objective, it's important to highlight these key skills to demonstrate your qualifications and suitability for the role. This section will discuss the essential skills that you should emphasize in your clinical researcher resume objective, which can significantly increase your chances of landing the job.

1. Biostatistics

Biostatistics is a crucial skill for a Clinical Researcher as it involves the application of statistical techniques to scientific research in health-related fields. It helps in designing robust experiments, analyzing and interpreting the data obtained from those experiments, and making informed decisions about treatments or interventions. This skill is necessary for a resume objective because it demonstrates the ability to effectively manage and analyze clinical trial data, which is essential for ensuring the validity and reliability of research results.

2. Epidemiology

Epidemiology is a crucial skill for a clinical researcher as it involves the study of how often diseases occur in different groups of people and why. This knowledge is fundamental in developing effective strategies to prevent illnesses and improve public health. It also allows the clinical researcher to understand and apply statistical techniques, design studies, collect and analyze health-related data, which are all critical tasks in clinical research. Including this skill in a resume objective shows potential employers that the candidate has the necessary expertise to conduct comprehensive research and contribute significantly to their field.

3. Data management

A Clinical Researcher often works with large volumes of data collected during clinical trials. This data needs to be properly managed, organized, and analyzed to produce accurate results and conclusions. Thus, having strong data management skills is crucial as it ensures accuracy, reliability and compliance with regulations. It also enables the researcher to efficiently monitor and track progress of the research, identify any issues or discrepancies in the data, and make informed decisions based on the data analysis. Including this skill in a resume objective can highlight one's ability to handle complex information effectively, which is a key requirement for this role.

4. Clinical trial design

Clinical trial design is a crucial skill for a Clinical Researcher as it demonstrates the ability to plan, implement, and manage research projects effectively. This skill is essential in ensuring that the trials are conducted ethically, safely, and accurately. It also shows an understanding of regulatory guidelines and standards which are vital in this role. Including this skill in a resume objective can highlight the candidate's capability to contribute significantly to the development and execution of clinical research studies.

5. Patient recruitment

A Clinical Researcher's role often involves conducting trials and studies that require the participation of patients. Having the skill of patient recruitment is crucial as it demonstrates the ability to effectively identify, engage, and enroll suitable candidates for various research studies. This skill shows the researcher's capability in communication, ethical considerations, understanding patient rights and maintaining patient confidentiality. It also reflects their ability to meet study objectives and timelines, ensuring the success of clinical trials.

6. Informed consent process

A Clinical Researcher needs to have a thorough understanding of the informed consent process as this is a critical aspect of any clinical trial or study. This skill demonstrates their ability to effectively communicate with participants, ensuring they fully understand the procedures, risks, benefits, and rights involved in the research. It also reflects their commitment to ethical practices and patient autonomy. Including this skill in a resume objective can highlight the candidate's competency in conducting responsible and ethical research.

7. Regulatory compliance

A Clinical Researcher is often responsible for conducting medical studies, trials, and research in compliance with regulatory standards. Understanding and adhering to these regulations is crucial to ensure the validity and legality of the research. This skill demonstrates a Clinical Researcher's knowledge of ethical guidelines, safety protocols, and legal requirements related to clinical trials and research. It shows their commitment to maintaining high-quality standards in their work, protecting patient rights, and ensuring the accuracy and reliability of their findings. Therefore, mentioning regulatory compliance as a skill in a resume objective can enhance a candidate's credibility and appeal to potential employers in the healthcare or pharmaceutical industry.

8. Protocol development

Protocol development is a crucial skill for a clinical researcher as it involves designing and implementing the procedures and guidelines for conducting clinical trials. This includes defining objectives, designing methodology, statistical analysis planning, and ensuring compliance with ethical standards. A strong understanding of protocol development demonstrates to potential employers that the candidate can effectively plan and manage research studies, ensuring they are carried out accurately, ethically, and efficiently. This skill is essential in achieving reliable and valid results in clinical research.

9. Safety monitoring

Safety monitoring is a crucial skill for a clinical researcher as it involves the ability to oversee and ensure the safety of all procedures and protocols in a clinical research setting. This includes monitoring patient safety during clinical trials, ensuring the correct handling of experimental drugs, and maintaining accurate records of any adverse events or reactions. This skill is essential for a resume objective as it demonstrates the candidate's commitment to ethical research practices, their ability to identify potential risks or issues, and their capacity to ensure the overall safety and well-being of participants in clinical studies.

10. Medical writing

A clinical researcher is often required to write research protocols, reports, and other documentation related to clinical trials. Medical writing skill is essential for this job as it ensures the production of high-quality, accurate, and clear documents that comply with regulatory standards. It also aids in effective communication with other healthcare professionals, participants, and stakeholders involved in the research. Hence, mentioning medical writing skills in a resume objective can highlight one's ability to handle crucial aspects of the job efficiently.

Top 10 Clinical Researcher Skills to Add to Your Resume Objective

In conclusion, the objective section of your clinical researcher resume is a pivotal platform to showcase your key skills. It's not just about listing skills, but emphasizing those that align with the specific job requirements and can demonstrate your potential value to prospective employers. Remember, this section serves as your first impression, so make it compelling and relevant. Tailoring your skills to match the job description can significantly increase your chances of landing an interview and ultimately securing the position.

Related : Clinical Researcher Skills: Definition and Examples

Common Mistakes When Writing a Clinical Researcher Resume Objective

Writing a resume objective for a clinical researcher position can be challenging. It is important to craft a statement that captures the attention of potential employers and accurately reflects your professional skills and experience. Unfortunately, many job seekers make mistakes when writing their resume objectives that can hinder their chances of landing an interview.

The first common mistake made when writing a clinical researcher resume objective is using generic language. While it’s important to be concise and highlight your relevant experience, generic phrases such as “seeking a challenging opportunity” or “looking for a rewarding career” won't capture the attention of recruiters. Instead, focus on specific skills you possess that are related to the position you are applying for and explain how you can use them to add value to the organization.

Another mistake commonly seen in clinical researcher resume objectives is failing to include quantifiable results from previous positions. Employers want to see evidence of past successes, so make sure you include any data-driven accomplishments that demonstrate your ability to contribute in the role. For example, if you managed projects or conducted research in the past, include metrics such as number of participants recruited or percentage of trials completed on time.

Finally, avoid including non-essential information in your resume objective such as hobbies or personal interests. These details may seem like they add personality to your application but they take up valuable space and do not provide any insight into why you are qualified for the job. Stick with information that directly relates to the specific position and illustrates how your background can benefit the employer.

By avoiding these common mistakes when writing a clinical researcher resume objective, job seekers will have an easier time getting noticed by recruiters and increasing their chances of landing an interview for their desired role.

Related : Clinical Researcher Resume Examples

Clinical Researcher Resume Objective Example

A right resume objective for a clinical researcher would be to showcase relevant experience and qualifications that demonstrate the ability to successfully conduct clinical research, while a wrong resume objective would focus more on generalities such as "seeking a challenging opportunity".

Editorial staff

Photo of Brenna Goyette, Editor

Brenna Goyette

Brenna is a certified professional resume writer, career expert, and the content manager of the ResumeCat team. She has a background in corporate recruiting and human resources and has been writing resumes for over 10 years. Brenna has experience in recruiting for tech, finance, and marketing roles and has a passion for helping people find their dream jobs. She creates expert resources to help job seekers write the best resumes and cover letters, land the job, and succeed in the workplace.

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