James "Jamie" O’Keefe leads the Research & Development (R&D) domain for CGI's Life Sciences Solutions practice, where he focuses on helping drive adoption of business capabilities such as: submissions management and archiving; IDMP; electronic management of Trial Master Files and investigator interactions; and defining and implementing risk-based monitoring programs. He has over 20 years of business and IT consulting experience, with the past 9 years focused in life sciences clinical and R&D. His expertise includes increasing efficiencies in clinical site monitoring and protocol optimization, as well as implementation of electronic Trial Master Files and clinical investigator portals. He is an active member of the Drug Information Association, where he sat on the Document Management SIAC working group for Trial Master File Reference Model recommendations.