Clinical Program Manager

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Presentation transcript:

Clinical Program Manager 14 May 2015 GS-US-337-1746(RESCUE) Investigator’s Meeting Welcome and Introductions Allison Fidelholtz Clinical Program Manager 08 December 2015 Confidential

Agenda – Tuesday December 08 2015 Time Discussion Item Presenter 9:00- 9:15 am Welcome, Introductions & Operational Structure Allison 9:15- 9:45 am Therapeutic Background & Study Rationale Lorenzo 9:45-10:35 am Protocol Overview Amanda 10:35-10:45 am Medical Monitoring 10:45-11:15 am Gilead Overview Enrollment Expectations Vendor Overview Electronic Data Capture Bracket IWRS Covance/Central Lab 11:15-11:30 am Q&A Session GSI Team

Gilead Study Team Structure Isobel Lakatos Director Allison Fidelholtz Clinical Program Manager Alis Vazquez Project Manager Anu Ghosalkar Sr. CTM Associate Winnie Tse Clinical Project Assistant Clinical Contracts & Finance Jennifer Clin Cntrcts & Finance Data Management Mark Gambino Clinical Data Associate I Medical Affairs Amanda Copans, Pharm D Study Director Lorenzo Rossaro, MD Medical Monitor

PRA Study Team