Clinical Trials SME

Key Role:

Apply problem–solving expertise with health or life science background to develop solutions to operational and strategic challenges for federal public health agencies. Work with project delivery teams to provide leadership and analytical support in the execution of project approaches and the development of deliverables and strategic recommendations to drive organizational improvements in business processes, program operations, strategic planning, policy effectiveness, and decision–making. Perform independent quantitative and qualitative data collection and analyses to derive insights on client issues, evaluate trends, and assess potential solutions. Develop and lead communications of practical solutions to clients in the form of data-driven presentations, briefings, and reports.

Basic Qualifications:

-6+ years of experience with medical product development

-1+ years of experience in working with clinical trials

-Knowledge of regulatory pathways

-Ability to work in a team-based or project environment

-Ability to lead projects or tasks

-Ability to obtain a security clearance

-BA or BS degree

Additional Qualifications:

-1+ years of experience in working with the FDA

-1+ years of experience with the health or medical product industries, including R&D, clinical, regulatory, marketing, strategy, operations, manufacturing, or consulting

-1+ years of experience with strategy or management consulting

-Experience with infectious disease biology

-Possession of excellent analytical skills

-Possession of excellent oral and written communication skills

-Secret clearance preferred

-MA or MS degree in Life Science or Engineering preferred

-Project Management Professional (PMP) Certification


Applicants selected will be subject to a security investigation and may need to meet eligibility requirements for access to classified information.

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