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.
Role type
TMF Document Coordinator II
Builds
eTMF systems for clinical trials
Domain
Clinical research / Biotechnology / Pharmaceutical (via careerplan.io/jobs/15-003-40-172-coordonnateurtrice-de-la-documentation-tmf-iitmf-document-coordinator-ii)
Required skills
TMF Reference Model knowledge, eTMF technologies, Microsoft Word/Excel, Good clinical practices (GCP), Health Canada/FDA regulations
Preferred skills
Process improvement, Computerized system administration
Responsibilities
Review TMF records for completeness and quality, Classify records and assign metadata, Identify quality issues and coordinate resolutions, Lead TMF activities for Investigator-Initiated Studies (IIS) and limited-scale studies, Manage TMF closeout activities, Generate TMF performance metrics and reports
Seniority
Mid-level, hands-on IC