Senior Clinical Project Manager
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About The Position
The Senior Clinical Project Manager reports directly to the Director Clinical Affairs and plays a critical role within TMC. This individual will lead all of the Company’s clinical research projects including strategy, execution, and budgetary planning and management. As the Clinical Affairs Project Manager, you will work closely with the Company’s marketing staff, KOLs, investigating physicians, and clinical research operations personnel (contractors), to manage all aspects of the company’s clinical studies, including assessing operational feasibility and recommending study execution plans; developing and managing comprehensive study timelines and metrics; overseeing the selection and management/oversight of external vendors while developing vendor specifications; reviewing vendor reports, budgets and metrics; preparing and presenting project debriefings as required; planning, executing, and leading study-specific meetings; and managing/participating in site-monitoring visits. You will be a hands-on leader and the point of contact for clinical trial sites. Will monitor and drive enrollment in studies, provide site screening and initiations, and interact directly with contracted monitoring and data management organizations, where utilized. You may also be involved in preparation of submissions to the FDA.
