Senior Clinical Data Manager

Statminds, Llc,   King Of Prussia, PA   Full-time     Information Services / Technology (IT)
Posted on September 25, 2021

Senior Clinical Data Manager

Duties: Perform quality checks using 360 Data Validation program, Business objects 4.2 & Spotfire computer tools. Perform Serious Adverse Event (SAE) reconciliation using Argus Safety Database; Use Output Delivery System (ODS) facility to write custom safety & efficacy reports directing outputs to PDF & HTML files. Utilize R tool to write code to generate standard graphs for internal publication & presentation; Develop clinical trial study dashboard & timeline using MS Project, Gantt, Visio, and Tableau tools during the study start-up. Generate & Review Case Report Tabulation (CRT) packages like Define.xml, XPT files & Reviewers Guide; Use quality review of data using J-Review visualization tool. Guide study team to prepare protocol deviation document for assigned studies for study start-up like Data Management Plan, Data Transfer Agreement, CRF Completion Guidelines etc. and other DM specific documents necessary during the course of the clinical trial; Coordinate, leads and perform clinical data management activities for assigned studies in accordance with Regeneron's SOPs, policies and practices; Raise and close queries in Medidata Rave, Oracle Inform, Datatrak, Medrio clinical databases; Lead, mentor and train others on specific departmental process including startup, conduct, closeout activities and change control processes.

Skills: J-Review visualization, Business objects 4.2, Spotfire, Argus Safety Database, ODS, Gantt, Visio, Tableau tools, Define.xml, XPT files, Medidata Rave, Oracle Inform, Datatrak & Medrio.

Must be willing to travel and/or relocate to work in unanticipated locations throughout the US. 

Requirements: Master’s degree with 6 months of experience in a job title with similar duties and skills.