Trial Master File Manager
In her role as TMF Manager for the Heart and Renal Studies, Hannah is responsible for setting up and maintaining the TMF in accordance with standard operating procedures and good clinical practice, ensuring that all essential documents are collected at central coordinating office, regional and site levels as required.
She manages the TMF administrators dealing with the day-to-day maintenance of the TMF, and leads discussions in order to move to an electronic TMF software system. Hannah is responsible for providing advice and guidance regarding both the TMF and the eTMF to groups within the CTSU and more widely across the University and regional coordinating centres, as well as being a main point of contact during audits and inspections.
Before working at the CTSU, Hannah was Deputy Head of Audit and Inspection Readiness at a TMF Technology company. Her background is in clinical research, working in industry for over five years on trials in different phases and therapeutic areas.