Sr Clinical Data Manager

Sr. Clinical Data Manager, Master’s degree in Bio-Informatics, Statistics with 1 year of experience; Develop Data management documents using Data Management Plan (DMPs), Data Transfer Agreement (DTAs), Data Clarification Form (DCFs), Data Query plans (DQPs) & Data Query Trackers; Build electronic data capture system in IBM Clinical Development (formerly Oracle Clinical(OS)) to capture all data required for data cleaning activities, study monitoring, & final analysis; Experience in data management repository tools (DCH), visualization (Spotfire) & provision tools and applications (SRT’s SAE Reconciliation Tool); Develop Statistical Software Suite programs to perform data clean activities including data review, query generation & integration, convert non-historical data and non-SAS data into SAS tables and to utilize available macro utility programs; Design paper case report forms, program specific reports using SAS, develop case report form completion guidelines, subject diaries, and source documentation, for each clinical trial as per project’s requirements on Interactive Web Response Systems (IWRS), IVRS (Interactive Voice Response systems), & online enrollment; Develop edit checks specification, perform data validation, discrepancy resolution & data review using Clintrial; Manage data discrepancy process during regulatory audit using PhOSCo; Lead database upgrades/migrations including performing User Acceptance Testing; Lead communication & discussion of matters related to data management task and deliverables and request for out-ofscope tasks; Skills: DCH , SAE Reconciliation, Spotfire, OS, SAS, IWRS, IVRS, edit checks specification, Clintrial & PhOSCo. Must be willing to travel and/or relocate to work in unanticipated locations throughout the US.Send Resume to PVR Technologies, Inc, 501 Allendale RD, Ste 201, King of Prussia, PA 19406.