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Associate Director, Trial Master File (TMF)

Position Summary

The Associate Director, Trial Master File (TMF) will report to a senior leader within Clinical Development Operations and is responsible for the strategic oversight, governance, and continuous improvement of the electronic Trial Master File (eTMF) across the clinical development portfolio.

This individual will ensure TMF processes, systems, and controls support inspection readiness, regulatory compliance, and efficient clinical trial execution. The role provides leadership over TMF strategy, vendor oversight, inspection preparedness, and cross-functional alignment, ensuring TMF completeness, quality, and timeliness throughout the study lifecycle.

The Associate Director serves as a key partner to Clinical Operations, Quality, Regulatory Affairs, and external vendors, maintaining sponsor accountability for TMF integrity while enabling scalable operations within a growing clinical-stage biotechnology organization.

Key Responsibilities

• Provide strategic leadership and sponsor oversight for the electronic Trial Master File (eTMF) across all clinical studies.
• Ensure TMF completeness, accuracy, and timeliness throughout the study lifecycle to support continuous inspection readiness.
• Lead the development, implementation, and maintenance of TMF governance processes, including SOPs, work instructions, and guidance documents.
• Establish and monitor TMF performance metrics and KPIs, leveraging data to identify trends, risks, and opportunities for improvement.
• Oversee CRO and vendor TMF activities, ensuring delegated responsibilities are executed in compliance with contractual and regulatory requirements.
• Serve as the TMF subject matter expert during audits, health authority inspections, and regulatory interactions.
• Drive risk-based TMF oversight, issue management, and CAPA development related to TMF quality or compliance findings.
• Partner cross-functionally with Clinical Operations, Quality, Regulatory Affairs, and Information Technology teams to ensure alignment and effective oversight.
• Lead or support TMF system implementation, optimization, validation, and change management activities.
• Develop and deliver TMF training and guidance for internal stakeholders and external partners.
• Ensure appropriate documentation of sponsor oversight and decision-making activities in accordance with ICH GCP and regulatory expectations.
• Support scalability and operational maturity of TMF processes as the clinical portfolio expands.
• Mentor and guide TMF team members, contractors, and external partners as applicable.

Qualifications

• Bachelor's degree in a scientific, healthcare, or related discipline; advanced degree preferred.
• Minimum 8–10 years of clinical research experience within biotechnology, pharmaceutical, or CRO environments.
• Demonstrated expertise in eTMF governance, inspection readiness, and regulatory compliance.
• Strong knowledge of ICH GCP (E6 R2/R3), TMF Reference Model, and global regulatory expectations.
• Experience operating within outsourced or CRO-driven clinical trial models, including sponsor oversight and vendor management.
• Hands-on experience with leading eTMF systems (e.g., Veeva Vault, Trial Interactive, Wingspan) and TMF metrics/KPI management.
• Proven track record supporting audits and regulatory inspections as a TMF subject matter expert.
• Experience developing and implementing SOPs, work instructions, and governance frameworks.
• Ability to assess TMF risk, manage issues and CAPAs, and drive continuous improvement initiatives.
• Strong cross-functional collaboration and influencing skills.
• Excellent written, verbal, and presentation communication abilities.
• Demonstrated leadership, organizational, and change management capabilities within growing organizations.

Desired Skills & Competencies

• Deep expertise in eTMF management, governance, and lifecycle oversight.
• Strong understanding of ICH GCP requirements and health authority expectations related to TMF.
• Ability to interpret and apply the TMF Reference Model pragmatically.
• Proven inspection-readiness mindset with the ability to defend TMF strategy and decisions.
• Demonstrated success providing sponsor oversight within outsourced clinical development models.
• Strong risk identification, assessment, and mitigation capabilities related to TMF quality and compliance.
• Experience managing TMF issues, deviations, investigations, and CAPAs.
• Ability to distinguish meaningful TMF risks from operational noise through data-driven decision making.
• Strong leadership and influencing skills across cross-functional and vendor organizations.
• Effective stakeholder management, including communication with senior leadership.
• Ability to translate detailed TMF data into actionable insights and executive-level narratives.
• Skilled at presenting complex compliance topics during audits and inspections.
• Experience developing and implementing governance models, SOPs, and operational processes.
• Strong change management capabilities within evolving or scaling organizations.
• Ability to balance compliance, structure, and agility in a fast-paced environment.
• Highly collaborative and capable of working effectively across Clinical Operations, Quality, Regulatory Affairs, and Technology functions.
• Strong organizational skills with attention to detail and prioritization.
• Comfortable operating in dynamic environments while maintaining compliance standards