The Role
The TMF Manager leads TMF strategy and operations for complex clinical studies, ensuring operational excellence and compliance while mentoring teams and fostering collaboration.
Summary Generated by Built In
The TMF Manager provides advanced leadership in Trial Master File (TMF) strategy and operations, independently guiding complex studies and ensuring excellence in TMF management. This role serves as a key escalation and decision-making point between study teams and TMF Operations, driving alignment and timely resolution. The TMF Manager strengthens organizational capability by fostering proactive issue management and promoting cross-functional collaboration to support the successful delivery of clinical studies.
Key Role Responsibilities
- Responsible for the strategic oversight and management of Trial Master File (TMF) operations across one or more complex clinical studies or programs.
- Serves as the primary TMF operations lead for complex studies, providing strategic oversight and proactive issue resolution across study teams.
- Demonstrates strong expertise in eTMF management systems, processes, and compliance requirements, ensuring inspection readiness and operational excellence throughout the study lifecycle. Key experience to look for would be experience within multiple eTMFs (either multiple systems or Veeva eTMF across multiple companies)
- Partners effectively with cross-functional study management teams and external stakeholders to anticipate challenges, drive solutions, and maintain high-quality documentation.
- Provides mentorship and guidance to Senior TMF Associates, fostering capability development and consistency across studies.
- Partner with study and program teams to define TMF strategies, governance, and milestones aligned with study timelines.
Qualifications
- 6–8 years of experience in clinical documentation or TMF operations within a CRO, sponsor, or pharma environment.
- Proven experience managing or leading TMF activities for complex, global, or late-phase clinical studies.
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*Accommodations are available for applicants with disabilities upon request throughout the recruitment lifecycle
Top Skills
Etmf Management Systems
Veeva Etmf
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The Company
What We Do
From 1986 to 2020 we operated as Robarts Clinical Trials and built a strong foundation in the medical research community. In 2020, we became Alimentiv but retained our commitment to clinical trials, medical imaging, and precision medicine for GI-related ailments.
