Senior Clinical Data Manager

PVR Technologies, Inc.   King Of Prussia, PA   Full-time     Administration / Clerical
Posted on January 21, 2023

Senior Clinical Data Manager

Duties: Design Case Report Forms in compliance with Clinical Data Acquisition Standards Harmonization & Study Data Tabulation Module standards; Generate metrics to study team using different reports such as 360 Query management report, query aging report & query detail report etc. Experience in multiple clinical EDC systems (Medidata Rave, imednet, IBM eCOs, Clin Spark etc; Develop, generate & analyze project progress reports, reporting summary of findings and remediation activities to Data management and project team; Track data management issues and ensure proper resolution and documentation; Work with Statistical Analysis System and/or clinical systems programming to produce data reports and data visualization tools to facilitate decision making on clinical trials; Train the study team like Clinical Research Coordinators, Clinical Research Associates on EDC navigation for data review, creation of queries, generate & review reports etc; Coordinates with Technical Design and Clinical Programming team to develop and test CRF and edit check specifications as well as EDC reports to support protocol requirements; Develop & test data management system edit / data validation checks and special listings / procedures used as tools for the data review and discrepancy management activities; Coordinates with the Electronic Data Capture programmers in setup and test of EDC technologies using Interactive Response Technology (IRT/IVRS/IWRS), and electronic clinical reported outcomes (eCOA); Verify reports created in EDC or other ad hoc reporting tool like J-Review, BOXI and associated change control requests; Ensure study-specific Data management documents in Trial Master File (TMF) are filed contemporaneously to support downstream inspection and submission readiness activities (Veeva Vault etc); Monitor database lock procedures, including all Quality Control efforts, in-line with company database lock requirements. Skills: EDC systems (Medidata Rave, imednet, IBM eCOs, Clin Spark, edit check specifications, J-Review, BOXI & Veeva Vault. 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.

Requirements: Master’s degree in Information System Engineering & Management, CIS with 2 years 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.