TMF Quality Specialist

Описание вакансии

*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 (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 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:

REQUIRED 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.

PREFERRED EXPERIENCE:

• 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.

REQUIRED 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: 0%

Physical Requirements and Working Conditions:

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
• 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).

Hourly Rate: $60.00

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities