PV RA MW Coordinator

Job Description

PV RA MW Coordinator

⢠Provides support and coordination of review of safety and regulatory publishing documents on receipt.

⢠Assists in reviewing document quality when tracking safety and regulatory publishing data in internal systems and uploading in internal and/or external electronic trial master files.

⢠Ensures redactions for Commercially Confident Information and Personal Data for regulatory publishing is maintained.

⢠Assists in maintaining the upkeep of licenses within internal and/or external systems for users across projects within IT Security standards.

⢠Coordinates/facilitates project meetings, drafts meeting minutes, posts minutes/materials to client portals and distributes to internal and external project teams.

⢠Manages project specific training and the set-up, maintenance and archival of program files; ensuring audit readiness.

⢠Identifies and redacts subject and client confidential identifiers per local requirements, retrains sites and escalates reoccurrences to PPD Data Privacy.

⢠Performs data entry into internal/external databases, tracking systems and PPD's budget management system; performs system reconciliations to identify issues which may negatively impact project timelines.

⢠Oversees expenses and manages translations; ensuring budget parameters are not exceeded.

⢠Assist with archiving of regulatory publishing documents and submissions.