TMF Implementation Specialist

Job Title: TMF Implementation Specialist
Location: King of Prussia, PA
Type: Contract - 1 year
Contractor Work Model: Hybrid – onsite and remote

Joule is seeking an experienced TMF Implementation Specialist to lead the setup and management of a paper-based Trial Master File (TMF). This contract role will play a critical part in building a compliant TMF from the ground up, organizing and maintaining essential study documentation in accordance with ICH-GCP and regulatory standards. The ideal candidate will bring hands-on experience with paper TMF systems, strong organizational skills, and the ability to work onsite in King of Prussia to support document handling, filing, and audit readiness activities.

Responsibilities

• Lead the implementation and maintenance of a paper-based TMF system for clinical studies.
• Develop and standardize TMF filing structures, indexing conventions, and document control procedures.
• Ensure TMF completeness, accuracy, quality, and inspection readiness throughout the lifecycle of clinical trials.
• File, organize, track, archive, and retrieve essential clinical documents in accordance with company SOPs and regulatory guidelines.
• Perform routine TMF quality reviews, reconciliation activities, and gap analyses to identify missing or incomplete documents.
• Create and maintain TMF-related plans, indexes, SOPs, work instructions, logs, and tracking tools

• Bachelor’s degree or equivalent combination of education and experience
• TMF management or clinical document management experience within the pharmaceutical, biotechnology, or CRO industry
• Hands-on experience implementing or managing paper TMF systems
• Familiarity with TMF Reference Model and inspection readiness standards
• Proficiency with Microsoft Office applications and TMF tracking tools

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

#LI- LI-EL1