Change Management: From Strategy to Practical Execution

About this session

Part of Session 4, Track E: TMF Culture and Engagement (Chair: Laurel-Ann Schrader, Transperfect).

In an environment marked by rapid growth, evolving regulations, and advancing technologies, leadership is critical to successful change within Trial Master File (TMF) operations. This session positions change management as a leadership-driven discipline that enables TMF teams to adopt new processes and technologies while maintaining inspection readiness, compliance, and data integrity.
Using real-world TMF scenarios - such as governance-led eTMF migrations, system and functionality enhancements, and the introduction of AI to support document processing and quality oversight - this session highlights how TMF Change Management Leaders shape culture, clarify ownership, and align cross-functional stakeholders.
Attendees will learn a practical change journey framework that TMF leaders can use to articulate purpose, set clear expectations, proactively manage risk, and demonstrate visible commitment. Emphasis is placed on how leadership behaviors, decision-making, and communication directly influence user adoption, audit outcomes, and sustained TMF performance.

Speakers

• RN

  Rhonda Nolan

  Regeneron Pharmaceuticals

  Speaker

• LS

  Laurel-Ann Schrader

  Transperfect

  Chair