TMF Quality Specialist (Contract)

The role

This contractor will support the review, quality oversight, and maintenance of Trial Master File (TMF) documentation. The role involves performing QC reviews, developing Oversight Review processes in Veeva Vault eTMF, and supporting system change requests.

What you will do

• Perform detailed QC reviews of TMF documents to verify metadata accuracy and compliance.
• Identify documentation gaps and collaborate with TMF Operations to resolve them.
• Support ongoing TMF review activities throughout the study lifecycle.
• Assist with audit and inspection preparation.
• Contribute to the continuous improvement of Oversight Review processes within Veeva Vault eTMF.
• Support the development of review standards, success metrics, and monitoring tools.
• Support TMF Operations leadership in identifying process improvement opportunities.
• Assist in preparing business requirements and participating in validation testing.
• Provide input into change control documentation.
• Help develop training materials, reference guides, and user communications.

Required qualifications

• Minimum 5 years of relevant experience in TMF Operations, including extensive hands-on work with Veeva Vault eTMF.
• At least 2 years performing TMF QC review.
• Experience supporting TMF planning, implementation, and configuration activities.
• Demonstrated understanding of the CDISC Reference Model, TMF structure, ICH/GCP, Good Documentation Practice, and regulatory documentation requirements.
• Experience partnering with or overseeing CROs performing TMF activities.
• Hands-on involvement in system reporting, dashboard development, or configuration testing within Veeva Vault.
• Exposure to multiple phases of clinical trial conduct.
• Proficiency in Microsoft Office Suite.
• Especially proficient in Excel for tracking, sorting, filtering, and managing large sets of metadata.
• Interpersonal skills, including conflict resolution in a fast-paced, deadline-driven environment.
• Strong attention to detail and organizational skills.
• Analytical skills to evaluate and interpret complex situations/problems.

Nice to have

• Familiarity with additional Veeva products such as CTMS or Vault RIM.

About the company

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics. The company's lead product candidate 4D-150 is designed to provide multi-year sustained delivery of anti-VEGF biologics.