Clinical Study Manager Jobs in Raleigh, NC (NOW HIRING)

Core Function Description:

Design and conduct epidemiological studies to generate real-world evidence within time, budget, and quality standards, including but not limited to natural history of disease, population characterization, assessment of treatment patterns and unmet need, development of external comparators, benchmarking of clinical outcomes, comparative safety and effectiveness research, and post-authorization studies. Skill sets of the Epidemiologist role are similarly required, with the expectation of more experience, able to operate strategically under limited supervision, well versed in current Epidemiology research methods, deep understanding of how RWE fits within drug development, regulatory, medical, safety and other functions.

Required Experience

• Lead development of study protocols, analysis plans, and study reports to answer research questions of priority to RWE.

• Lead, design, and manage epidemiological, biomarker and/or data science projects.

• Lead, plan, design, and conduct analyses for internal and external decision making (e.g., responses to regulatory authorities, rapid analyses of safety queries).

• Lead the identification of fit-for-purpose data for the timely execution of the RWE strategy.

• Constructed cohorts using RWD sources (e.g., claims, EHR) and evaluate key variables, including diagnosis and procedures codes, and plan validation studies as needed.

• Contribute to the communication of observational research results and methods, including development of pertinent sections of regulatory documents, reports, publications, white papers.

• Support the effective communication of study/analysis results to support internal and external decisions.

• Coauthor abstracts and manuscripts for external dissemination of methodologic study results.

• Contribute to the development of processes and training aimed at increasing the efficiency, quality, and impact of functional activities.

Technical Expertise:

• Observational research methods (both Primary and Secondary), deep knowledge of biostatistics and analysis methods, understanding of regulatory processes.

• Ability to design studies independently, (i.e., ability to translate research questions to create study design).

Subject Matter Expertise:

• Provide subject matter expertise and conduct analyses for descriptive and comparative research using RWD (examples include claims, EHR, PRO/COA, registry data) for methodologic research questions.

• Deep, hands-on familiarity with EHR data curation behind health system firewalls, including practical knowledge of where key clinical outcomes are captured across data tables.

• Expert knowledge and extensive experience with pharmacoepi methods (i.e., signal detection and validation methods).

• Leverage RWE expertise to identify evidence gaps and develop options to address the evidence gaps in support of Clinical Development Programs.

Minimum Qualifications

• PhD in Epidemiology with a minimum of 4 years of relevant post-doctoral experience, preferably within a pharmaceutical company or pharma consulting environment. Master's degree in epidemiology plus 7-9 years of experience in lieu of PhD may be acceptable.

• Extensive experience in retrospective claims data studies required. Focused data sources are mainly US (some ex-US) claims data and lab data.

• Experience in HIV treatment, defining complex treatment patterns required.

• Deep understanding of observational research methods and experience to support the design and conduct of observational research, including protocol, statistical analysis plan, and study report development.

• A record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation is preferred.

• Demonstrated ability to function with an increasing level of autonomy and to develop productive cross- functional collaborations in a matrix environment.

• Ability to manage priorities and performance targets.

What's in it for you?

• Be part of a forward-thinking team that helps shape the next generation of evidence-based healthcare.

• Work hand-in-hand with one leading sponsor, gaining deep expertise in their therapies.

• Access IQVIA's global network who supports your growth.

This is your chance to make an impact, while building a career that matters.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more athttps://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.