Job Information
ThermoFisher Scientific Sr PV RA MW Coordinator in Remote, Philippines
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.
• 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.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.