Sr PV RA MW Coordinator

Work Schedule

Environmental Conditions

Job Description

• 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.

• Coordinates the timely review of protocol inquiries, serious and non-serious

adverse events, diagnostics, and source documents; tracks

all necessary data and generates reports for the client, project team and/or

external vendors.

• 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 raises reoccurrences to PPD Data Privacy.

• Develops training materials and supports management with project budgetary

management.

• Supports department management in reporting financial, contractual and budget

data.

• Provides project specific services, documentation and coordination of projects

and supports reporting of same to management, internal and external clients.

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

• Coordinates expenses and handles translations; ensuring budget parameters are not exceeded.

• Assist with archiving of regulatory publishing documents and submissions.

• Mentors and trains junior staff.