Job Title: Associate Director, Trial Master File, Clinical Operations

Work Location: Remote

Summary:

This role provides strategic oversight and governance of Trial Master File (TMF) activities across clinical programs, ensuring continuous inspection readiness and regulatory compliance. The position is responsible for leading TMF quality initiatives, developing sustainable processes, and supporting pivotal studies and regulatory submissions.

Responsibilities:

• Direct TMF strategy, build, maintenance, and governance for clinical programs, ensuring alignment with regulatory submission timelines and inspection requirements.
• Establish and uphold TMF governance standards, quality metrics, and provide executive-level visibility into TMF health and risks.
• Define and enforce filing standards, naming conventions, and metadata governance in accordance with industry models and regulatory guidelines.
• Develop and manage TMF quality reporting tools, dashboards, and outputs to enable proactive oversight and informed decision-making.
• Support study teams in creating and executing Study TMF Filing Plans and Expected Document Lists (EDLs).
• Implement a risk-based TMF Quality Control framework, including ongoing health checks and pre-inspection reviews to ensure documentation completeness and audit readiness.
• Lead TMF gap assessments, remediation initiatives, and maintain TMFs in a continuous state of inspection readiness, including preparation for regulatory inspections.
• Oversee CRO and vendor TMF performance, drive cross-functional accountability for TMF compliance, and serve as the escalation point during inspections.

Qualifications:

• Bachelor’s degree in a related field with 8+ years of experience in biotech/pharma within Clinical Operations, TMF, and/or GCP Quality.
• Strong knowledge of ICH-GCP, regulatory requirements, and cross-functional clinical trial processes.
• Experience supporting Health Authority inspections (e.g., FDA, EMA) preferred.
• Working knowledge of the DIA TMF Reference Model and TMF best practices.
• Experience with Veeva eTMF/Clinical systems and electronic document management systems strongly preferred.
• Solid understanding of TMF compliance, auditing processes, and inspection readiness expectations.
• Familiarity with regulatory inspections related to NDA/BLA/MAA submissions preferred.
• Excellent interpersonal and influencing skills in a cross-functional, matrixed environment.
• Proven ability to manage complex priorities, drive continuous improvement, and work independently with a proactive mindset.
• Strong organizational, analytical, and problem-solving skills with the ability to meet tight timelines.

Published Category: Clinical Operations & Development