Work Schedule
Other
Environmental Conditions
Office
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.
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• 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.