Trial Master File (TMF) Specialist

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Requirements:

• Bachelor’s degree in a scientific discipline or equivalent experience.
• Minimum of 3-4 years of biotech/pharmaceutical industry or CRO experience.
• Knowledge of the DIA TMF Reference Model and GCP requirements.
• Experience managing TMF documents and conducting quality control activities.
• Understanding of data privacy principles such as HIPAA and GDPR.

Responsibilities:

• Support implementation and management of record management processes related to the eTMF and ensure compliance with policies.
• Serve as a subject matter representative and guide team members on documentation best practices.
• Prepare and manage TMF Plans and Content Lists, ensuring study team and vendor compliance.
• Perform eTMF quality reviews, identify deficiencies, and track resolution.
• Maintain eTMF quality metrics and facilitate TMF QC activities.