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.
Provide TMF support for both inspection and audit activities for internal and external hosted audits.
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 TMFs
ICH/GCP guidelines
TMF reference model knowledge
ALCOA++ principle
Nice-to-have
Process excellence and consistency
Risk mitigation and contingency planning
Dynamic atmosphere
Zero tolerance for candidate fraud
Key Requirements
Minimum 5 years of experience
BS/BA in Life Sciences or similar discipline
Experience with various eTMF systems
Experience managing paper TMF is preferred
Previous experience with internal/ external audits and inspection is an asset