This position will oversee the global eTMF (electronic Trial Master File) operations for GRD R&D including providing support to all study teams members involved in eTMF management
Job Summary
This position will oversee the global eTMF (electronic Trial Master File) operations for GRD R&D including providing support to all study teams members involved in eTMF management.
Responsible for creation and revision of all eTMF associated procedures, ensuring they are up to date and compliant with the applicable regulations.
This position will assume the leadership role for global eTMF operation to ensure the quality KPIs are met and eTMFs are inspection ready at all times.
Matching Summary
This position will oversee the global eTMF (electronic Trial Master File) operations for GRD R&D including providing support to all study teams members involved in eTMF management.
Skills & Requirements
Must-have
Global eTMF operations oversight
eTMF procedures creation and revision
Inspection ready TMF maintenance
eTMF set-up, maintenance, QC/QR
ICH GCP and applicable regulations knowledge
Good Document Practice requirements
Nice-to-have
Process excellence and consistency
Risk mitigation and contingency planning
Leadership for global eTMF operation
Dynamic atmosphere working environment
Key Requirements
Minimum 5 years of experience
BS/BA in Life Sciences or similar discipline
Experience with various eTMF systems
Experience managing paper TMF preferred
Previous experience with internal/ external audits