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Clinical Project Manager

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Description:

The Clinical Project Manager (CPM) is responsible to provide clinical input for product development planning, development and produce clinical protocols, and perform project timeline management and tracking. The CPM is charged to integrate good clinical practices and best organizational practices into the overall drug development plan. Coordinate and generate necessary materials for clinical trial initiation; develop and produce clinical protocols, amendments, and administrative letters; oversee work assignment and deliverables for CROs, independently contracted managers or other specified resources; manage and track global clinical resource expenditures per project; timeline management and tracking. Collaboration on and review of clinical documents (e.g. investigator brochures, annual IND safety reports, integrated clinical study reports). Contribute to generation, refinement and maintenance of clinical operations infrastructure; comply with ICH, federal U.S. and any pertinent local regulations; timely completion of clinical trial milestones and internal development work; and ensure integrity of the clinical database. Ensure accuracy of study-specific and department information disseminated both internally and externally.

 






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