TMF Quality Specialist (Contract)
About The Position
4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery GENERAL SUMMARY We are seeking a TMF Quality & Oversight Specialist, reporting to the Director of TMF Operations. This contractor will support the review, quality oversight, and maintenance of Trial Master File (TMF) documentation in accordance with GCP, ICH E6, regulatory requirements, and 4DMT SOPs. In addition to QC review, the role will help develop and execute Oversight Review processes in Veeva Vault eTMF and support system change requests by representing the Business Process Owner (BPO) perspective. This work is critical to strengthening TMF oversight and ensuring inspection readiness.
Requirements
- 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, applying knowledge of clinical documentation content and metadata standards.
- Experience supporting TMF planning, implementation, and configuration activities, including review of TMF Plans and participation in system setup or enhancements.
- Demonstrated understanding of the CDISC Reference Model, TMF structure, ICH/GCP, Good Documentation Practice, and regulatory documentation requirements.
- Proficiency in Microsoft Office Suite for collaboration with team members.
- 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 including the ability and drive to follow through on detailed tasks to closure.
- Analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.
Nice To Haves
- 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 (startup through close-out and TMF archiving).
- Familiarity with additional Veeva products such as CTMS or Vault RIM.
Responsibilities
- Perform detailed QC reviews of TMF documents to verify metadata accuracy, confirm proper filing, and ensure compliance with ICH GCP, regulatory standards, and internal SOPs.
- Identify documentation gaps, inconsistencies, or quality issues and collaborate with TMF Operations team members to resolve them promptly.
- Support ongoing TMF review activities throughout the study lifecycle to help ensure quality, timeliness, and completeness.
- Assist with audit and inspection preparation by supporting the TMF team in documentation readiness activities.
- Contribute to the continuous improvement of Oversight Review processes within Veeva Vault eTMF, including workflows, dashboards, and metrics.
- Support the development of review standards, success metrics, and monitoring tools that provide visibility into TMF quality, completeness, and inspection readiness.
- Support TMF Operations leadership in identifying process improvement opportunities and contributing to the development of new tools, workflows, and best practices.
- Assist in preparing business requirements, documenting user needs, and participating in validation testing and user acceptance activities from the BPO perspective.
- Provide input into change control documentation and support cross-functional collaboration with IT, Quality, and Managed Services teams during configuration updates.
- Help develop training materials, reference guides, and user communications to support adoption of new functionality or process changes.
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What This Job Offers
Career Level
Mid Level
Education Level
No Education Listed
