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TMF Manager
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Full-time
- TMF Manager 2019498
- Job Overview: This role will be responsible for supporting the study management team with TMF process development, process implementation, and oversight of TMF management, working closely with the SMT Functional Area Leads and the Quality team to ensure smooth operations within the Clinical Operations department.
- Act as the primary TMF contact and Subject Matter Expert (SME), supporting the clinical study team and cross-functional departments in TMF process education for an inspection-ready eTMF.
- Lead the development of SOPs, TMF-related plans, and system configurations, implementing process improvements and creating training tools.
- Maintain complete oversight of eTMF document filing, ensuring accuracy and compliance with company standards, Good Clinical Documentation Practices, and project-level Trial Master File Plan and Index.
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