Quick overview
Job description
Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.
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 biologics (aflibercept and anti-VEGF-C) with a single 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 and the second indication is diabetic macular edema, which are both in Phase 3 development. 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.
We are taking genetic medicine to new heights and into new disease areas to overcome challenges not addressed by existing medicines. This incredible challenge drives our relentless and talented team. Our people are the essence of our inspiring, innovative and collaborative environment that encourages individual contributions and provides opportunities for career development. We seek the best in the industry who identify with our mission and our bold and innovative results-driven approach. Our Core Values drive the way we work together:
- Dare to Cure
- Break Boundaries
- Beyond Yourself
- Prepare & Execute Relentlessly
Join us in creating the future of genetic medicine.
GENERAL SUMMARY
We are seeking a TMF Quality & Oversight Specialist, reporting to the Senior Manager, Clinical Records. 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.
MAJOR DUTIES & RESPONSIBILITIES:
QC Review & Documentation Support
- 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.
Oversight Review Process Development
- 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.
Business Process Owner (BPO) Support for System Enhancements
- 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.
QUALIFICATIONS:
Experience:
- 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.
- 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.
Other Qualifications/Skills:
- 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.
Travel: N/A
Physical Requirements and Working Conditions:
- Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
- Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).
Base salary compensation range: $52.00-$61.00/ hour
Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.