TMF Operations Lead

Location: This position may be performed remotely, but requires flexibility and willingness to travel as needed.

Primary Responsibilities:
- Serve as TMF subject matter expert and trusted partner, providing guidance on TMF requirements, expectations, and best practices throughout the clinical trial lifecycle.
- Lead setup, maintenance, quality review, and closeout of electronic Trial Master Files (eTMFs) ensuring they are complete, accurate, contemporaneous, and inspection ready.
- Monitor TMF health (completeness, timeliness, quality) against study milestones; translate metrics into insights, risks, and recommended actions.
- Partner with Clinical Operations, external vendors, and cross-functional stakeholders to maintain document lists, resolve gaps, and ensure filing within timelines.
- Identify, investigate, and drive resolution of TMF issues (missing/late/poor-quality); escalate significant risks with clear ownership.
- Support inspection readiness (audits and regulatory inspections) by ensuring TMF documentation/processes meet applicable global requirements.
- Contribute to continuous improvement of TMF procedures, work instructions, training, systems, and operating practices.

Qualifications / Key Success Factors:
- Bachelor’s degree in life sciences, healthcare, or related field; 5+ years progressive TMF operations/management experience in biotech/pharma/clinical research.
- Deep working knowledge of ICH-GCP, FDA requirements, and other applicable global TMF/clinical trial documentation regulations.
- Strong eTMF platform experience; Veeva Vault eTMF strongly preferred.
- Expert understanding of TMF structure, lifecycle management, quality controls, and inspection readiness.
- Ability to assess TMF health, interpret metrics, identify risks, and drive issue resolution.
- Comfortable working autonomously, speaking up on risks, and taking ownership.

Annualized Base Salary: $99,000 USD - $119,000 USD