Work Schedule

Environmental Conditions

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.

Qualifications:
Education and Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Technical positions may require a certificate
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at
least 2 years).