TMF Specialist

The TMF Specialist serves as the subject matter expert for all aspects of the Trial Master File (TMF). This role is responsible for overseeing TMF configuration, ensuring quality control across studies, and supporting compliance with regulatory standards.

Responsibilities

• Act as the TMF expert for all studies and provide guidance on best practices.
• Configure study binders within Egnyte or similar eTMF platforms.
• Manage user access to TMF binders and perform quality control of filed documents.
• Support QA teams in developing and delivering TMF-related training programs.
• Oversee data migration activities, such as transitioning Phase II TMF from paper to Egnyte.
• Collaborate with CRO partners to ensure smooth TMF transition for Phase III studies.

• End-to-end TMF expertise, including systems and processes.
• Ability to train others on TMF and QA processes.
• Experience with Egnyte or other eTMF platforms.
• Proficiency in document management and clinical trial inspection readiness.

• Experience with Veeva and Veeva Vault.
• Strong skills in clinical documentation and data migration.

This role requires working on-site 3-4 days a week. The company focuses on developing therapies for serious, rare genetic skin diseases with no FDA-approved treatments, offering employees the chance to be part of a team addressing unmet medical needs. The organization emphasizes its expanding pipeline of therapies and positions itself as a leader in rare dermatology. The 2024 Equity Incentive Plan demonstrates a commitment to rewarding employees with ownership opportunities, aligning personal success with company success.

Job Type & Location

This is a Contract position based out of Philadelphia, PA.

Pay and Benefits

The pay range for this position is $45.00 - $60.00/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)

Workplace Type

This is a hybrid position in Philadelphia,PA.

Application Deadline

This position is anticipated to close on Dec 12, 2025.

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 : $45 - $60