The Important Role Of The Study Owner In Guiding The TMF

By Justyna Alsztyniuk, lead customer success manager, PharmaLex

The trial master file (TMF) has become a growing priority for pharmaceutical companies and regulators alike. Effective TMF management ensures compliance and inspection readiness, making the role of the study owner—also known as a TMF manager or TMF lead—essential. Tasked with maintaining oversight, study owners coordinate stakeholders, monitor key performance indicators (KPIs), and drive continuous improvement.

Study owners act as subject matter experts, ensuring regulatory requirements are met while promoting TMF completeness and accuracy. From setting up and maintaining the TMF to supporting audits and inspections, they provide strategic oversight. Additionally, their responsibilities include identifying root causes of issues, managing corrective actions, and fostering collaboration across departments.

To excel, study owners need comprehensive regulatory knowledge, technical proficiency, and strong interpersonal skills. Their ability to analyze data, offer constructive feedback, and champion TMF best practices directly impacts study success. As the cornerstone of TMF management, they ensure the TMF remains a reliable record of clinical trial conduct.

Discover how study owners can elevate TMF management, drive compliance, and ensure your organization remains inspection-ready. Read more to explore practical strategies and insights.