Associate Director of TMF Operations
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Job Summary
To lead TMF transformation and operations, the full-time remote Associate Director of TMF Operations will manage strategy, governance, and oversight to ensure a governed, inspection-ready TMF operating model while collaborating with cross-functional teams.
Key Responsibilities:
- Lead the TMF operating model, including strategy, governance, and standards to support the portfolio
- Define and implement TMF processes and KPIs to promote consistency, quality, and compliance across studies and vendors
- Oversee TMF across all programs, ensuring alignment with ICH-GCP and global regulatory expectations
Required Qualifications:
- BS/BA degree required; advanced degree highly desirable
- 6-8 years of clinical research experience with significant TMF/eTMF leadership experience
- Proven experience in building and leading TMF frameworks in an outsourced or hybrid operating model
- Deep expertise in TMF strategy, governance, and inspection readiness
- Extensive experience with eTMF systems, including system governance and optimization
Complete Job Description
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