Sr. TMF Specialist – Remote (USA-NC)
Job ID: 25104074 | Updated: December 3, 2025
Employer: Syneos Health
About the Role
Syneos Health is a globally recognized, fully integrated biopharmaceutical solutions organization supporting clinical development, medical affairs, and commercial operations. As a Sr. TMF Specialist, you will play a key role in managing Trial Master File (TMF) activities to ensure documentation quality, regulatory compliance, and operational excellence across clinical studies.
This position supports the full TMF lifecycle, including set-up, maintenance, and closeout, while ensuring alignment with SOPs, GCP, ICH guidelines, and study-specific requirements. The role is fully remote within the United States.
Key Responsibilities
Process and manage study documentation according to SOPs, Work Instructions, GCP, ICH, and study-specific guidelines.
Support TMF set-up, maintenance, and closure for assigned clinical trials.
Manage documentation collection, scanning, indexing, and quality control activities within the electronic TMF.
Ensure secure handling and compliance of all active and archived study documents.
Conduct Quality Review and Completeness Review of TMF content, ensuring adherence to expected document lists.
Collaborate with document owners to resolve inconsistencies, errors, or gaps in TMF documentation.
Escalate significant issues to the TMF Lead and complete required administrative and reporting tasks.
Support TMF preparation and reconciliation for audits, inspections, and regulatory submissions.
Participate in study-specific and role-specific training programs.
Maintain compliance with internal standards including time tracking, training, productivity, and quality requirements.
Develop, update, and cross-reference compliance trackers and tools.
Create expected document lists using the TMF Reference Model with guidance from TMF or Study Teams.
Work with Line Managers to identify and implement TMF best practices focused on quality, productivity, and communication.
Provide oversight, mentoring, and training to junior TMF/document management staff as needed.
Support development and enhancement of TMF processes, SOPs, and departmental guidelines.
Demonstrate strong multitasking ability, accuracy, and attention to detail.
Experience Required
3–5 years of hands-on experience in TMF management, eTMF systems, clinical documentation, or clinical operations within a CRO or pharmaceutical environment.
Strong working knowledge of GCP, ICH, TMF Reference Model, and regulatory documentation standards.
Experience with TMF audits, inspections, and document quality control processes.
Prior experience mentoring or supporting junior team members is preferred.
Qualifications
Bachelor’s degree in Life Sciences, Health Sciences, Clinical Research, or a related discipline (or equivalent experience).
Proficiency in electronic TMF systems and document management tools.
Strong organizational, communication, and problem-solving skills.
Compensation
Salary Range: USD $47,000 – $79,900
Actual compensation depends on skills, experience, and role-specific competencies.
Why Join Syneos Health
Career development, training, and advancement opportunities.
Competitive benefits including medical, dental, vision, 401(k) match, and employee stock purchase eligibility.
Flexible paid time off and sick leave coverage aligned with state and federal regulations.
Supportive, inclusive, and collaborative work culture committed to employee well-being and professional growth.
About Syneos Health
Over the past five years, Syneos Health has partnered on
94% of all Novel FDA-Approved Drugs
95% of EMA-Authorized Products
200+ clinical studies across 73,000 sites
Syneos Health combines clinical expertise, scientific insights, and operational innovation to accelerate development and improve patient outcomes.
Summary
The Sr. TMF Specialist is responsible for supporting the end-to-end management of the Trial Master File, ensuring documentation completeness, accuracy, and audit readiness in alignment with global regulatory standards and client expectations.
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