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Clinical Study Team Lead (Director)
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- Clinical Development expert focused on the execution of clinical studies and brings that expertise to the design & conduct of clinical studies in alignment with the program and portfolio strategies for the specific category(ies)/Therapeutic Areas.
- Responsible for proactive risk management and inspection readiness for their clinical study(ies).
- Develops and leads execution of the data and document delivery plans at key milestones such as POC, DP3 decisions, submissions, and rapid response.
- Leads and coordinates the execution of a clinical studies from Sourcing Strategy and Study Specification development for Requests for Proposals, Study start-up through Database release and inspection readiness to ensure timely delivery of quality study data.
- Utilizes negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross functional study team performance and accountable for effective study team operations and team health.
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