Job Information
PVR Technologies Inc SR. CLINICAL DATA MANAGER in King Of Prussia, Pennsylvania
Manage process of training EDC users. Design clinical trials utilizing CDASH & SDTM standard terminology; Lead the team in understanding integrated data review process (IDRP) and supporting technology ecosystem including medical and statistical review capabilities; Experience in Clinical databases such as Medidata Rave, Oracle Clinical, Veeva, & Clinplus Database, Medidata Suite products (Safety Gateway, ePRO, RTSM); Guide Clinical Data Management team in tasks around EDC go-live (coordinating the start of Interactive Web Response System (IXRS) transfers, EDC access, availability of reports and database extracts; Guide team of biostatistician and SAS programmers to compile & maintain SAS data dictionary; Manage system integrations across data platforms & Output data listing using J Review or SAS Tools. Skills- CDASH, SDTM, Medidata Rave, Oracle Clinical, Veeva, & Clinplus Database, Medidata Suite products (Safety Gateway, ePRO, RTSM, J Review or SAS Tools. MUST BE WILLING TO TRAVEL AND/OR RELOCATE TO WORK IN UNANTICIPATED LOCATIONS THROUGHOUT THE US.