TMF Specialist

Job Title: TMF Specialist / Senior TMF Specialist

Job Description

The TMF Specialist / Senior TMF Specialist supports the day-to-day operational management, maintenance, and remediation of Trial Master File (TMF) documentation across seven clinical studies. This role ensures that approximately 45,000 TMF documents from non-active studies are accurately scanned, filed, indexed, classified, and maintained in alignment with internal procedures, the TMF Reference Model, study-specific TMF plans, and applicable regulatory requirements. The position plays a key role in maintaining inspection-ready TMFs and supporting cross-functional clinical development activities.

Responsibilities

• Manage the end-to-end lifecycle of TMF documentation for multiple clinical studies, ensuring accurate scanning, filing, indexing, classification, and maintenance.

• Apply sponsor procedures, the TMF Reference Model, and study-specific TMF plans to organize and maintain TMF content consistently and compliantly.

• Perform TMF uploads and document filing activities in Veeva Vault eTMF and Veeva Clinical platforms.

• Execute detailed document classification and indexing, including accurate metadata management to support efficient TMF retrieval and oversight.

• Conduct TMF completeness reviews to confirm that required documents are present and appropriately filed for each study.

• Perform quality reviews of TMF content to identify gaps, inconsistencies, and quality issues, and drive remediation activities to resolve them.

• Support large-scale TMF remediation and cleanup initiatives, including both paper and electronic TMF records.

• Reconcile TMF documents against study plans, trackers, and other source records to ensure consistency and completeness.

• Create, maintain, and update TMF metrics, trackers, and completeness reporting to provide visibility into TMF health and inspection readiness.

• Contribute to TMF inspection readiness initiatives by ensuring documentation is organized, complete, and aligned with ICH-GCP and regulatory expectations.

• Work in inspection-ready environments and support internal and external stakeholders during audits and inspections as needed.

• Collaborate cross-functionally with Clinical Operations, Quality Assurance, Regulatory Affairs, Medical Writing, Data Management, Safety, CROs, and vendors to resolve TMF-related issues and align on documentation expectations.

• Utilize TMF dashboards and metrics reporting tools, and support risk-based TMF oversight models to prioritize and manage TMF activities.

• Manage multiple priorities and deadlines across several studies in a fast-paced clinical development environment.

• Identify TMF risks and issues proactively, escalate them appropriately, and contribute to problem-solving and continuous improvement efforts.

• Maintain strong attention to detail and a high level of quality in all TMF management activities.

• Communicate effectively with internal teams, CROs, vendors, and external stakeholders to coordinate TMF tasks and ensure alignment on documentation standards.

Essential Skills

• For Senior TMF Specialist: minimum 5+ years of clinical research experience with significant hands-on TMF/eTMF management experience.

• For TMF Specialist (Junior): minimum 2+ years of clinical research experience with significant hands-on TMF/eTMF management experience.

• Strong expertise with Veeva Vault eTMF and Veeva Clinical platforms.

• Proven experience performing TMF uploads, document filing, classification, indexing, metadata management, and document reconciliation activities.

• Experience working with paper-based studies and paper TMF documentation.

• Strong knowledge of the TMF Reference Model and sponsor-specific TMF filing conventions.

• Experience conducting TMF completeness reviews, quality reviews, and remediation activities.

• Solid understanding of ICH-GCP requirements and TMF regulatory expectations.

• Experience supporting TMF inspection readiness initiatives and working in inspection-ready environments.

• Ability to create and maintain TMF metrics, trackers, and completeness reporting.

• Experience with regulatory documents and document management in a clinical research setting.

• Strong attention to detail and a consistent commitment to quality.

• Excellent organizational and time management skills with the ability to manage multiple priorities and deadlines across studies.

• Effective communication and collaboration skills for working with internal teams, CROs, vendors, and external stakeholders.

• Proactive problem-solving skills with the ability to identify and appropriately escalate TMF risks and issues.

Additional Skills & Qualifications

• Experience supporting sponsor and/or CRO TMFs across multiple clinical studies.

• Experience with large-scale TMF remediation projects and cleanup initiatives.

• Experience working with both paper and electronic TMF systems.

• Familiarity with TMF dashboards, metrics reporting, and risk-based TMF oversight models.

• Ability to work cross-functionally with Clinical Operations, QA, Regulatory Affairs, Medical Writing, Data Management, Safety, CROs, and vendors.

• Comfort working in a fast-paced clinical development environment supporting multiple studies simultaneously.

Work Environment

This role operates in a fast-paced clinical development environment that supports multiple clinical studies at the same time. The position is based in Bedford, MA, with a hybrid work arrangement of approximately two to three days onsite per week and the potential to transition to a fully remote setup over time, subject to confirmation. You will work closely with cross-functional partners in Clinical Operations, Quality Assurance, Regulatory Affairs, Medical Writing, Data Management, Safety, CROs, and external vendors, using Veeva Vault eTMF and Veeva Clinical platforms as core systems for TMF management. The environment emphasizes inspection readiness, high-quality documentation, and strong collaboration across teams.

Job Type & Location

This is a Contract position based out of North Billerica, MA.

Pay and Benefits

The pay range for this position is $42.00 - $58.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in North Billerica,MA.

Application Deadline

This position is anticipated to close on Sep 17, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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