Entry-Level Trial Master File (TMF) Specialist
Core
Manage the Trial Master File (TMF) to ensure data integrity and support the successful execution of clinical trials for drug and device development.
Role type
Entry-level Trial Master File (TMF) Specialist
Builds
Clinical trial documentation and regulatory submission packages
Domain
Clinical research / Biopharmaceuticals
Deliverable
Dashboards & analysis
Required skills
TMF management, TMF Specifications creation, folder structure setup, TMF Plan review, TMF Quality Control (QC) support, audit/inspection readiness review, report development, metric reporting
Preferred skills
Life science background, Microsoft Office proficiency, Adobe Acrobat proficiency
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
Entry-level, hands-on IC
