Trial Master File Specialist
Core
Manage the Trial Master File (TMF) to ensure data integrity and support FDA approval for new drugs or devices.
Role type
Clinical Trial Master File Specialist
Builds
Regulatory-compliant clinical trial documentation
Domain
Clinical research / Biopharmaceuticals
Required skills
TMF management, TMF Specifications creation, folder structure setup, TMF Plan review, TMF Quality Control (QC) support, audit/inspection readiness, training and mentoring
Preferred skills
Life science background
Technologies
Microsoft Office, Adobe Acrobat
Responsibilities
Provide guidance and support to study team members and sponsors regarding TMF management; Initiate and manage TMF Specifications based on scope of work, protocol, and other core documents; Set up and maintain study specific TMF folder structure; Support CTMs with review of TMF Plans; Support study team(s) during periodic TMF QCs by assisting with report development and metric reporting; Report on TMF Health to Sponsors and CTMs; Contribute to audit/inspection readiness activities by reviewing the TMF, TMF Specifications, and TMF Plans for accuracy, consistency, and completeness; Train and mentor other TMF staff.
Seniority
Individual Contributor
