Senior Clinical Data Manager

PVR Technologies, Inc   King Of Prussia, PA   Full-time     Information Services / Technology (IT)
Posted on June 5, 2021

Senior Clinical Data Manager

Duties: Manage EDC Database Specifications, CRF design, validation of clinical database, CRF Completion Guidelines, Data Management Plans, Data Review Plan & Data Transfer Agreements to ensure data quality; Support integration of datasets in SDTM\CDISC compliant standards for Phase I to III clinical trials; Design & build studies on EDC platforms such as Medrio, Rave, iMednet, Bioclinica, Oracle Inform, Trial Master etc. along with other data collection systems such as ePRO, IRT, Argus 2; Create Rave custom reports, functions & integrations to extract/load clinical data for drugsafety, SAS datasets, IxRS, LABS, and CTMS including generating reports for manual data review using reporting tools such as J-Review, I-Review and BOXI; Implement changes on EDC along with UAT completion & eTMF documentation. Perform clinical data review for efficacy, safety & interpretation of tables, listings, and analysis to ensure clinical data reported as per GCP, FDA, ICH, CDASH regulations and guidelines. Skills: J-Review, I-Review, BOXI, SDTM, CDISC, SAS, Rave, Oracle Inform, Medrio, iMednet, & Trial Master. Must be willing to travel and/or relocate to work in unanticipated locations throughout the US. 

Requirements: Master’s degree with 1 year of experience in a job title with similar duties and skills.