Remote Director, TMF Strategy & Compliance

Celea Therapeutics; Boston (MA); Remote; USD 215,000 - 245,000; Full time

Job summary

Celea Therapeutics is seeking a Director, Trial Master File (TMF) to establish and maintain TMF standards, processes, and oversight across the clinical development portfolio. You will partner with Clinical Operations, Quality Assurance, CROs, and external partners to drive accountability and sustainable improvements in TMF quality.

In the near term, focus includes Phase 3 readiness, risk-based monitoring, and strengthening eTMF processes while ensuring timely document management, reconciliation,

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• 10+ years in clinical research, TMF management, or related ops.
• 5+ years leading TMF teams or document mgmt functions.
• Experience with global trials across phases; regulatory inspections.
• Strong knowledge of ICH‑GCP, FDA/EMA regs; TMF lifecycle.

Responsibilities

• Provide strategic leadership for the TMF program across the portfolio.
• Ensure regulatory compliance, risk-based quality management, and governance.
• Oversee TMF lifecycle from start-up through closeout and archival.
• Monitor TMF quality metrics, risks, and escalation; drive improvements.
• Lead TMF inspection readiness and support regulatory inspections.

Skills

Leadership

Strategic thinking

Regulatory knowledge

Stakeholder management

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

eTMF systems (Veeva Vault, Trial Interactive, Wingspan, Florence)

Job description

Celea Therapeutics is seeking a Director, Trial Master File (TMF) to establish and maintain TMF standards, processes, and oversight across the clinical development portfolio. You will partner with Clinical Operations, Quality Assurance, CROs, and external partners to drive accountability and sustainable improvements in TMF quality.

In the near term, focus includes Phase 3 readiness, risk-based monitoring, and strengthening eTMF processes while ensuring timely document management, reconciliation,