Associate Director, Trial Master File Lead

Dyne Therapeutics

Waltham, United States
**
Global tmf strategy development
Tmf governance frameworks
End-to-end tmf oversight
** Dyne Therapeutics is seeking an Associate Director, Trial Master File Lead, who will spearhead the global strategy for Trial Master File (TMF) management, ensuring compliance with regulatory requirements and high-quality clinical execution. This role involves close collaboration with various departments to enhance TMF processes and governance frameworks. **

Job Summary

  • The Associate Director, TMF Lead is responsible for developing and driving the global TMF strategy, establishing and maintaining robust governance frameworks, and ensuring end to end oversight of the Trial Master File across the clinical portfolio.
  • This role serves as the enterprise owner of TMF processes, quality standards, and inspection readiness, ensuring that TMF operations meet regulatory requirements, support high quality clinical execution, and operate efficiently at scale.
  • This role partners closely with Clinical Operations, Quality, Regulatory, and external vendors to ensure a unified, proactive approach to TMF health, completeness, and compliance.

Matching Summary

Match Score: 75

** Dyne Therapeutics is seeking an Associate Director, Trial Master File Lead, who will spearhead the global strategy for Trial Master File (TMF) management, ensuring compliance with regulatory requirements and high-quality clinical execution. This role involves close collaboration with various departments to enhance TMF processes and governance frameworks. **

Skills & Requirements

Must-have

  • global TMF strategy development
  • TMF governance frameworks
  • end-to-end TMF oversight
  • regulatory requirements compliance
  • inspection readiness

Nice-to-have

  • proactive approach to TMF health
  • continuous improvement initiatives
  • scalable TMF operating models

Key Requirements

  • TMF strategy and leadership
  • Governance and process ownership
  • TMF lifecycle management
  • TMF roles and responsibilities
  • CAPA management

Work Rights

Not specified

Tailored Resume

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