Coordonnateur(trice) de la documentation TMF II/TMF Document Coordinator II
Core
Maintains the Sponsor's Trial Master File (TMF) throughout clinical trials by reviewing, classifying, and quality-controlling records to ensure compliance with regulatory standards. (via careerplan.io/jobs/15-003-40-172-coordonnateurtrice-de-la-documentation-tmf-iitmf-document-coordinator-ii-at-indero)
Role type
Clinical Trial Master File (TMF) Coordinator
Builds
eTMF systems and regulatory-compliant document repositories for clinical trials
Domain
Clinical Research / Biotechnology / Pharmaceuticals
Required skills
TMF Reference Model knowledge, eTMF technology proficiency, ICH-GCP regulations, study milestone management, document classification, quality control workflows, Microsoft Word/Excel
Preferred skills
Investigator-Initiated Studies (IIS) management, process improvement, computerized system administration
Technologies
eTMF, Microsoft Word, Microsoft Excel
Responsibilities
Review TMF records for completeness and accuracy; classify records and assign metadata; identify and resolve quality issues; maintain study milestones and document lists; generate TMF metrics and reports; lead TMF activities for limited-scale studies; manage TMF closeout activities.
Seniority
Mid-level, hands-on IC