15+ years in TMF, documentation excellence, and clinical records governance

TMF
Helen Park
Director, Trial Master File and Documentation Excellence
Documentation memory and TMF readiness lead
This is a fictional representative profile. The downloadable resume is a role-level template for readers, not a real person's CV.
Qualifications
Why this person belongs in Dr. Liang's group
Representative fictional career profile using real pharmaceutical, biotech, and clinical research organizations as market references to show the level of background expected for this role.
TMF plan design, essential document completeness, QC workflows, inspection storyboarding, archive readiness, and document owner accountability.
Device, BA/BE, respiratory rescue, oncology, pediatric, and global closeout programs.
Qualified because she ensures the trial can be reconstructed from records, not merely remembered by the project team.
Representative Career Path
- Director, TMF Operations, Johnson & Johnson
- Clinical Documentation Lead, Roche
- TMF Quality Manager, IQVIA