Lisa Mulcahy

Lisa has a 20 above year career in the pharmaceutical industry, primarily in the areas of clinical operations and quality management. More than seven years ago she became an independent consultant, focusing solely on Trial Master File process and management assisting clients with the assessment and improvement of their current state, the development of future design, and the implementation of systems for the management of electronic records of the TMF. She is experienced in the quality assessment of study-specific TMFs. She is a frequent speaker and experienced workshop leader at TMF-related professional meetings.

Lisa is co-leader, with Karen Roy of Phlexglobal, as well as a Steering Committee member of the volunteer team of industry representatives through the DIA that created, maintains and expands the TMF Reference Model.