Job Title: Lead TMF Specialist
Department: Clinical Operations
Location: Remote, Colombia
Job Type: Regular Full-Time
Job ID: 2525
About Emmes Group:
Emmes Group is on a mission to shape the future of clinical research, striving to bring life-changing medical discoveries within reach for patients around the globe. With over 47 years of expertise, we have evolved from supporting U.S. government research to becoming a trusted partner in public-private ventures and commercial biopharma. Our proven strength lies in critical therapeutic areas such as vaccines, cell and gene therapy, infectious diseases, ophthalmology, rare diseases, and neuroscience.
We are committed to cultivating a workplace that thrives on performance, innovation, and collaboration. If you are passionate about advancing medical research and want to be part of a people-driven company, join us.
Primary Purpose:
The Lead TMF Specialist serves as the functional TMF lead on assigned studies, ensuring that the Trial Master File (TMF) is audit and inspection-ready at all times. This role drives TMF completeness, leads documentation activities, oversees TMF specialists, and ensures adherence to corporate SOPs and industry best practices. You’ll be a subject matter expert (SME) on eTMF systems and processes, building partnerships with internal teams and sponsors to maintain high-quality documentation throughout the study lifecycle.
Key Responsibilities:
Act as SME in TMF processes, eTMF applications, and document identification/filing.
Own and manage the TMF Plan/Index; identify expected documents and track study events.
Review Statement of Work (SoW) to align TMF activities accordingly and distinguish between in-scope and out-of-scope tasks.
Maintain study TMFs in accordance with ICH/GCP guidelines and TMF Reference Models.
Collaborate with sponsors on TMF practices and represent TMF Operations in audits and inspections.
Provide mentorship and guidance to TMF Specialists on study documentation best practices.
Lead the development of SOPs, templates, and quality control guidelines related to TMF activities.
Support eTMF feature implementation and system change management with Clinical Systems Manager.
Gain expertise in both internal and sponsor-selected eTMF platforms, especially Veeva Vault.
Drive innovation in TMF processes using automation, RPA, AI, or ML technologies.
Execute lifecycle tasks in eTMF applications (set-up, EDL updates, metrics, reviews, close-out, archiving, etc.).
Required Qualifications:
Bachelor’s degree, preferably in a scientific discipline.
Minimum 5 years of experience in Clinical Operations or TMF management.
Strong knowledge of eTMF applications and filing procedures.
Experience ensuring TMF inspection readiness and identifying documentation gaps.
Proficiency in Veeva Vault is highly desirable.
Project management experience is a plus.
In-depth knowledge of GCP and TMF regulatory standards, including TMF Reference Model.
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