Senior TMF Specialist
Location: Remote (USA – NJ)
Job ID: 25104073
Updated: December 3, 2025
Company: Syneos Health
About the Role
Syneos Health is a fully integrated biopharmaceutical solutions organization supporting clinical development across global markets. The Senior TMF Specialist plays a key role in managing, reviewing, and maintaining Trial Master File (TMF) documentation in compliance with regulatory, operational, and quality standards. This position ensures complete, accurate, inspection-ready documentation to support clinical trials across diverse therapeutic areas.
Key Responsibilities
Manage and process clinical study documentation according to SOPs, Work Instructions, GCP, ICH guidelines, and study-specific requirements.
Support TMF setup, maintenance, and close-out activities across assigned trials.
Conduct document collection, scanning, indexing, and archiving within the electronic TMF system.
Ensure secure handling and compliance of documents for active and archived studies.
Perform Quality Review and Completeness Review of TMF content based on Expected Document Lists.
Collaborate with document owners to resolve discrepancies and escalate issues to the TMF Lead when needed.
Contribute to audit and inspection readiness through TMF reconciliations and document preparation.
Maintain adherence to organizational requirements including time tracking, training completion, productivity, and quality metrics.
Develop and maintain TMF compliance tools, trackers, and study-specific documentation lists.
Work closely with line management to identify TMF best practices and enhance documentation processes.
Provide training and guidance to junior team members when required.
Support development of SOPs, workflows, and internal documentation for TMF management.
Required Experience and Qualifications
Bachelor’s degree in Life Sciences, Clinical Research, Health Sciences, or a related field.
3–6 years of relevant experience in TMF management, clinical documentation, or clinical operations.
Strong understanding of GCP, ICH guidelines, and TMF Reference Model standards.
Proficiency with electronic TMF systems and document management platforms.
Excellent organizational skills with high attention to detail and accuracy.
Ability to multitask and work independently in a fast-paced, deadline-driven environment.
Experience supporting audits, inspections, and TMF quality controls preferred.
Why Join Syneos Health
Syneos Health provides a collaborative environment focused on continuous learning, inclusion, and professional development. Employees benefit from:
Comprehensive health coverage including medical, dental, and vision plans
401(k) with company match
Flexible paid time off and sick leave (subject to local regulations)
Employee Stock Purchase Program
Recognition programs and career advancement opportunities
Compensation
Salary ranges vary based on qualifications, experience, and job-related competencies. Final compensation will reflect individual expertise and organizational standards.
About Syneos Health
Over the past five years, Syneos Health has supported:
94% of FDA-approved novel therapies
95% of EMA-authorized products
200+ clinical studies across 73,000 sites and 675,000+ trial participants
Learn more at syneoshealth.com
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