Associate Director, Trial Master File Lead

Role Summary

The Associate Director, Trial Master File (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.

Responsibilities

• TMF Strategy & Leadership
  • Define and own the company’s TMF strategy, including innovation opportunities and continuous improvement initiatives
  • Lead the development and implementation of scalable TMF operating models, ensuring alignment with clinical development goals
  • Serve as the internal subject matter expert on TMF best practices, regulations, and inspection trends
  • Represent TMF leadership in cross functional forums, governance committees, and senior level operational discussions
• Governance & Process Ownership
  • Establish and maintain TMF governance frameworks, including policies, SOPs, work instructions, and quality standards
  • Oversee TMF lifecycle management—from planning and setup through closeout and archival
  • Define TMF roles, responsibilities, and RACI structures across internal teams and vendors
  • Monitor adherence to processes and drive corrective and preventive actions (CAPAs) related to TMF quality issues
  • Ensure timely collection, review, and management of TMF documents from clinical study teams and external partners
• TMF Oversight & Compliance
  • Provide strategic oversight of TMF operations, including ongoing quality reviews, completeness assessments, and key performance indicators (KPIs)
  • Ensure TMFs across the portfolio remain inspection ready
  • Lead TMF related preparation for audits, inspections, and regulatory submissions, ensuring all documentation is complete and accurate
  • Analyze TMF metrics and trends to proactively identify risks, gaps, and improvement opportunities
• Vendor & Technology Management
  • Oversee TMF service providers, CRO partners, and technology platforms to ensure alignment with TMF requirements
  • Partner with IT and business stakeholders to optimize the eTMF system, workflows, and integrations
  • Ensure vendors adhere to contractual obligations, performance expectations, and quality standards related to TMF
  • Stay up to date with industry trends and regulatory requirements related to TMF management and documentation practices
• Cross Functional Partnership & Support
  • Collaborate with cross-functional study teams to guide TMF planning, milestones, and document management expectations
  • Provide training, coaching, and strategic direction to internal and external partners on TMF processes and regulatory requirements
  • Advise leadership on TMF health and organizational readiness for key regulatory events

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred
• 8+ years of experience in clinical operations, document management, or related GxP environment, with significant TMF expertise
• Strong knowledge of ICH-GCP, TMF Reference Model, and global regulatory expectations
• Proven experience developing TMF strategy, governance frameworks, or enterprise level processes
• Ability to lead cross-functionally without authority; demonstrated leadership in managing TMF operations or oversight at a portfolio level
• Experience working with eTMF systems and CRO/vendor oversight
• Excellent communication, influencing, and stakeholder management skills