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Associate Director / Director, Trial Master File Management
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- Reporting to the Vice President of Clinical Operations, the Trial Master File (TMF) Associate Director / Director serves a key role, working across the organization for the execution of TMF Operations processes and strategy.
- The TMF Associate Director/ Director will provide tactical support and strategic guidance on TMF processes, filing conventions, index creation, maintenance, and other
- The TMF Associate Director/ Director will play a pivotal role in creating and maintaining consistency across studies and programs to ensure essential trial documents are appropriately collected, indexed, stored and accessible, while adhering to regulatory and Morphic standards.
- Implement and maintain TMF quality control processes that are aligned to internal standards, regulatory requirements, and GCP.
- Build collaborative relationships with CROs; drive the timely filing of documents throughout the study cycle; provide process and/or tactical support for TMF-related remediation as needed.
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