TMF Specialist - Remote

Overview

The TMF Specialist is a vital member of the study team, responsible for ensuring a high quality and complete electronic Trial Master File (eTMF) for ongoing clinical trials, supporting compliance with regulatory requirements.

In Short

• Support implementation and management of eTMF processes.
• Serve as a subject matter expert for clinical study teams.
• Prepare and manage TMF Plans and Content Lists.
• Conduct eTMF quality reviews and track document deficiencies.
• Maintain eTMF quality metrics and create reports.
• Oversee TMF quality for both QED and CRO TMFs.
• Facilitate TMF QC activities and track issues.
• Support regulatory inspections as a subject matter expert.
• Coordinate with CRO and study vendors for timely issue resolution.
• Support ongoing TMF maintenance and archival activities.

Requirements

• Bachelor’s degree in a scientific discipline or equivalent experience.
• 3-4 years of experience in biotech/pharmaceutical or CRO.
• Knowledge of the DIA TMF Reference Model.
• Understanding of GCP and regulatory requirements.
• Experience managing TMF documents.
• Proficient in MS Excel and MS Word.
• Knowledge of data privacy principles (HIPAA, GDPR).
• Excellent organizational skills and attention to detail.
• Positive, team-oriented attitude.
• Remote position; SF Bay Area based is preferred.

Benefits

• Patient Days to hear from individuals living with conditions.
• A culture inspired by values: patient-first, transparency, and science-driven.
• Access to learning and development resources.
• Market-competitive compensation and benefits package.
• Flexible PTO.
• Rapid career advancement for strong performers.
• Commitment to Diversity, Equity & Inclusion.