Senior Clinical Data Manager

PVR Technologies, Inc   King Of Prussia, PA   Full-time     Information Services / Technology (IT)
Posted on May 4, 2021

Senior Clinical Data Manager, MS. degree in Computer & Info Science, IT., with 1 year of experience, Mentor project & study teams to ensure understanding of clinical data standard & procedure using CDISC & CDASH std.; Oversee or perform quality control on clinical database validate by performing user acceptance test in Medidata Rave & escalate issues identified to program.; Make clinic data for inter. analysis & to reg. agencies using reporting tools like BOXI, Spotfire, BO4 & J-Review; Integrate & test ext. system/dev. such as IWRS, IVRS, & ePRO with CTMS, including implementation of such system.; Oversee data entry staff to ensure data quality & pro. study-spe. data entry training; Lead dev. of SOPs, Working. Proc., & Guidance doc. based on SDTM & CDISC controlled term.; Lead data revision meetings with Medical, Clinical, Biostatistics & Programming in support of key reporting events (Ex., FDA) or database lock plans. Must be willing to travel and/or relocate to work in unanticipated locations throughout the US.