Consultant, Clinical Project Lead, Medical Devices

Employment Type

: Full-Time


: Miscellaneous

Summary: Our client, a global medical device manufacturer, has engaged GForce Life Sciences to identify a Clinical Project Lead who will be responsible for various aspects of assigned clinical studies, from protocol drafting through study summary and final report. Duties / Expectations: Draft clinical study protocols and prepare all technical reports, abstracts, and presentations required for assigned studies Upon completion of an assigned study, compile a final report and summary of study results Interpret and present study findings to colleagues, including members of the leadership team Review relevant medical & scientific literature, study results, and data to stay up-to-date with trends in laboratory medicine Identify necessary testing to address clinical risks for product changes Provide consultation, from a clinical standpoint, for HEOR studies, HFE studies, and post market studies Ensure safety, efficacy, and clinical utility of the assigned product Mandatory Requirements: Bachelor of Science in Biology, Biochemistry, or related field 1-3 years of clinical laboratory or clinical research experience is required, with medical device experience being highly preferred Must have experience drafting clinical study protocols Demonstrated knowledge of technical writing and clinical study design Knowledge of laboratory workflow related to blood collection and handling Nice to Have Requirements: Advanced degree in a health-related field MT (ASCP) or equivalent is desirable Project management experience Previous experience working on clinical trials IVD experience is a plus Term & Start: Start ASAP 12 + month contract Must be in Northeastern New Jersey or willing to relocate.

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