As the Director of Document Management for Advanced Clinical, JP Miceli is responsible for all CRO and FSP TMF activities. JP oversees all TMF staff, project management, business development and budgeting, TMF migrations, implementations and system deployment, and acts as the eTMF system administrator and owner. JP’s background includes more than twenty years of industry experience at sponsor and CRO organizations, with a primary focus on GxP records management and clinical documentation. JP has been a member of the TMF Reference Model group since 2010, has previously served on the Change Control Board and as the Zone Team Liaison, and currently sits on the Steering Committee.
In this session, discover what it takes to establish and maintain a healthy eTMF that works for your team while ensuring a high level of quality and oversight.
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