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PVR Technologies Inc SR. CLINICAL DATA MANAGER in King Of Prussia, Pennsylvania

Communicate with the Clinical Operations team to develop and maintain system specifications for EDC systems (e.g., Medidata RAVE) based on study-specific requirements; Collaborate with various functional areas to create clinical data reports using reporting platforms such as J-Review, R-Programming, & Spotfire; Using Rave Architect and eCRF design tools, create, develop, and review case report forms (CRFs); Create annotated CRFs in accordance with CDISC-CDASH requirements; Work with SAS programmers on SAS dataset building and data analysis for safety and efficacy studies. Oversee the training process for EDC users and the implementation of clinical trials utilizing CDASH standard nomenclature; Lead team in understanding the clinical data review (CDR) process and supporting the technological environment. Skills: Medidata RAVE, J-Review, R-Programming, Spotfire, CDISC-CDASH, SAS dataset.Must be willing to travel and/or relocate to work in various worksites throughout the US.

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