TMF Manager

As a Trial Master File (TMF) Manager, you will play a pivotal role in maintaining TMFs to ensure they are current and inspection-ready for both internal and external entities. This position reports to the Associate Director of TMF Operations or higher. You will need a strong understanding of clinical trial conduct, TMF structure (TMF Reference Model), eTMF systems, and best documentation practices.

• Manage clinical document quality, control, and review, as well as the Trial Master Files (TMFs).
• Perform setup activities and provide oversight of internal e/TMF applications.
• Support Clinical Operations Study Leaders in quality control and oversight of CROs’ e/TMF applications.
• Serve as a functional lead for specified e/TMF platforms with vendors.
• Provide support and guidance to CROs and support staff to ensure accurate and timely eTMF filing and maintenance according to ICH GCP guidelines.
• Provide training to eTMF users and external parties, such as CROs.
• Partner with management and others to support functional and organizational initiatives, drive new procedures and ideas, and advocate for processes and decisions.
• Support the development and review of standard operating procedures and work instructions related to clinical document management.
• Contribute to the maintenance of written instructions, SOPs, guidelines, and plans as they relate to e/TMFs and document control.
• Update and maintain Naming and Filing Guide(s) for relevant e/TMF systems.
• Collaborate with all applicable functional areas.
• Work in collaboration with Clinical Operations Management to drive new procedures and processes within the department.

• Bachelor’s degree or equivalent combination of education and experience in science or health-related field.
• Minimum of 5 years of e/TMF experience in a pharmaceutical, biotechnology company, or contract research organization.
• Thorough knowledge of all sections of the TMF Reference Model (current and previous versions).
• Thorough knowledge of documents from various functional areas and their appropriate e/TMF filing requirements.
• Thorough knowledge of International Council for Harmonization (ICH) Good Clinical Practice (GCP) and Good Documentation Practice (GDP) principles.

• Experience with eTMF system or software including development of SOPs, user training manuals, and performing UATs and validations.
• Thorough knowledge of electronic TMF applications, for major non-proprietary systems, and ability to prioritize related tasks based on project goals.
• Experience working with multiple eTMF vendors and CRO partners.

The role operates in a hybrid work environment, requiring the candidate to be local to the Cambridge area. The candidate should be able to travel onsite approximately twice per month, sometimes on short notice.

This is a Contract position based out of Cambridge, MA.

The pay range for this position is $75.00 - $85.00/hr.

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)

This is a hybrid position in Cambridge,MA.

This position is anticipated to close on Mar 18, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $75 - $85