Associate Director, Trial Master File

Role Summary

In alignment with strategic direction, the Associate Director, TMF will provide leadership and operational oversight of the Trial Master File (TMF) function to ensure inspection-ready, high-quality clinical documentation across the organization. This role will partner cross-functionally with Quality Assurance and IT to optimize TMF processes, systems, and compliance. The Associate Director will lead a team responsible for day-to-day TMF management, metrics, and reporting, while driving continuous improvement initiatives and ensuring adherence to ICH GCP, Good Documentation Practices (GDocP), and all applicable regulations. The Associate Director will also partner with cross-functional leads to promote a culture of inspection readiness across the clinical trial portfolio.

Responsibilities

• Provide leadership and oversight of TMF operations, ensuring inspection readiness and compliance with global regulations and internal standards.
• Manage and mentor TMF staff, fostering a culture of accountability, quality, and professional development.
• Oversee and optimize use of Veeva Vault eTMF and ensure alignment with business needs and best practices.
• Partner with Veeva Managed Services and Clinical Systems Manager to resolve issues, implement system enhancements, and ensure operational excellence.
• Lead TMF metrics and reporting, including completeness, timeliness, and quality, providing transparency to senior leadership.
• Serve as a subject matter expert for ICH GCP, GDocP, CDISC TMF Reference Model (formerly DIA TMF Reference Model), and global clinical trial regulations.
• Support with audits and regulatory inspections, including preparation, backroom support, and follow-up activities.
• Support CAPA management: drafting, implementation, tracking, and closure for TMF related quality events.
• Support authoring, reviewing, and maintaining SOPs, Work Instructions, and training materials, plans related to the TMF.
• Support in maintaining and performing change control on company TMF Content Map.
• Drive change management initiatives to improve TMF processes, systems, and culture in a matrixed environment.
• Partner with stakeholders on process improvement projects and conduct TMF training across clinical and study teams.
• Ensure proper TMF configuration and adoption that may have impact on adjacent Veeva Clinical Suite applications such as, CTMS, Site Connect, Study Training, Study Start-up.
• Collaborate cross-functionally to ensure TMF expectations are clearly defined, implemented, and monitored throughout study lifecycles.
• Other duties as assigned.

Qualifications

• Required: Bachelor’s degree in Life Sciences, Healthcare, or related field; advanced degree preferred.
• Required: Minimum 10 years of experience in TMF Operations within the pharmaceutical, biotech, or CRO industry.
• Required: A minimum of 7 years in a supervisory role; demonstrated people management experience, including performance management and team development.
• Required: Proven expertise with Veeva Vault eTMF.
• Required: Experience working with Veeva Managed Services to implement improvements and resolve issues.
• Required: Strong background in TMF metrics and reporting.
• Required: Hands-on experience in audits/inspections (e.g., FDA, EMA, MHRA).
• Required: Experience in CAPA lifecycle management.
• Required: Proficiency in SOP and WI development, training, and implementation.
• Required: Strong knowledge of ICH GCP, GDocP, global clinical trial regulations, and CDISC TMF Reference Model.
• Required: Demonstrated ability to lead change management initiatives and influence in a matrixed environment.
• Required: Strong interpersonal and communication skills, with the ability to partner effectively across functions and levels.
• Required: Excellent organizational, analytical, and problem-solving skills with attention to detail.
• Preferred: Experience with working with Veeva CTMS, Site Connect, Study Training, Study Start-up in relation to TMF process flows.
• Preferred: Experience in process transformation and implementation of tools to streamline TMF operations.
• Preferred: Familiarity with risk-based TMF management approaches.
• Preferred: Experience in global/multi-regional clinical trial environments.
• Preferred: Strong project management skills and ability to balance multiple priorities in a fast-paced environment.

Education

• Bachelor’s degree in Life Sciences, Healthcare, or related field required; advanced degree preferred.

Additional Requirements

• Travel: You may be required to travel for up to 5% of your time.
• Physical Demands: Some walking and lifting up to 25 lbs may be required; sit at a desk for extended periods.