TMF Lead II
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Job Summary
Leading Trial Master File (TMF) management activities, the full-time remote TMF Lead II will ensure compliance with industry standards while overseeing the setup, maintenance, and closure of TMFs, providing training and status updates to project teams and stakeholders.
Key responsibilities
- Acts as the primary TMF point of contact for project teams, Sponsors, auditors, and other third parties
- Develops and maintains TMF Plans, TMF Transition Plans, and indexes for assigned studies
- Monitors compliance with TMF SOPs and provides regular status updates on document submissions
Required qualifications
- Minimum of a high school diploma or international equivalent; undergraduate degree preferred in a relevant field
- 8+ years of experience with eTMF systems
- 8+ years of Trial Master File management experience
- 8+ years of TMF Reference Model experience
- 2+ years of TMF Lead experience
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