Senior Clinical Data Manager

PVR Technologies, Inc,   King Of Prussia, PA   Full-time     Information Services / Technology (IT)
Posted on September 11, 2021

Senior Clinical Data Manager

Duties: Lead, train & mentor junior team members on specific departmental process including startup,conduct, closeout activities and change control processes; Manage & provide oversight to CRO (Contract Research Organizations) for clinical trial implementation & data reconciliation process; Develop and update clinical Trial Master files (TMF) using Rave PDF Generator, Veeva Vault & Pulse 2.0; Oversee database query management & subsequent resolution in Medidata Rave, Datatrak, Medrio & Oracle Inform; Manage vendor data files on sFTP (secure File Transfer Protocol) tools, ensuring integrity & security of vendor data; Perform review of data using J-Review visualization tool & implement quality checks using Business objects 4.2, Spotfire, J-review, etc. across all studies; Direct & provide guidance to Clinical Data Associates for SAE reconciliation, SAE email alerts, SAE report guidelines; Develop clinical trial study dashboard & timeline using MS Project, Visio, and Tableau during study start-up & provide insight to study leadership team on major deliverables. Skills: Rave PDF Generator, Veeva Vault, Pulse 2.0, Medidata Rave, Datatrak, Medrio, Oracle Inform, J-Review, Business objects 4.2, MS Project, Visio, & Tableau. 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 the job offered or in the related occupation