At Biomapas, I lead eTMF setup, maintenance, and quality oversight, working hands-on with Veeva Vault eTMF. I help ensure clinical trial documentation is complete, accurate, compliant, and inspection-ready.
At PSI, I managed TMF activities across up to 20 clinical trial projects at a time and coordinated an international team of up to nine employees. I also supported preparation for and participation in more than 40 TMF audits and regulatory inspections.
As PSI Document Center Manager, I managed document operations and TMF and eTMF maintenance, developed region-specific Quality System Documents, and trained staff on document management processes and systems.
I’ve worked across electronic and paper TMF documentation throughout my career, from archiving and review to process development and audit support. My work is grounded in GCP and ICH GCP E6(R3).
