Senior Clinical Data Manager

PVR Technologies, Inc King Of Prussia, PA Full-time Information Services / Technology (IT)

Posted on May 11, 2024

DUTIES: 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.

REQUIREMENTS: Master’s degree in Information Technology, Computer Science with 1 year of experience in a job title with similar duties and skills.

Feel free to send resume to PVR Technologies, Inc, 501 Allendale RD, Ste 201, King of Prussia, PA 19406.