Transitioning from a study coordinator to roles in clinical operations and then Quality Assurance, a significant portion of my initial responsibilities involved managing the Trial Master File (TMF) to ensure it was audit-ready. This role deepened my understanding of the meticulous detail required to comply with all government regulations and study protocols throughout the conduct of a study. Furthermore, it broadened my knowledge of the necessary documentation and correspondence for clinical trials.

As an experienced TMF manager, I have had the opportunity to work in various settings, whether dealing with paper-based or electronic systems. This experience has kept me well-versed in the regulatory requirements essential for storing and maintaining a TMF.