Senior TMF Specialist (Remote, NC) | Clinical Document Management
Location: North Carolina, USA (Remote)
Job ID: 25104074
Updated: December 3, 2025
Overview
Syneos Health® is a fully integrated biopharmaceutical solutions organization committed to accelerating clinical development and improving patient outcomes. We are seeking a Senior Trial Master File (TMF) Specialist to join our remote North Carolina team. This role is ideal for professionals experienced in TMF management, document control, and regulatory compliance within clinical research.
As a Sr. TMF Specialist, you will play a critical role in ensuring the completeness, accuracy, and compliance of Trial Master Files for global clinical studies while mentoring junior team members and contributing to process improvements.
Key Responsibilities
Manage study documentation according to Standard Operating Procedures (SOPs), Work Instructions (WIs), ICH-GCP guidelines, and study-specific requirements.
Support the set-up, maintenance, and closure of TMF repositories for active and archived studies.
Collect, scan, index, and quality review study documents within an electronic TMF environment.
Perform completeness reviews against Expected Document Lists (EDLs) to identify gaps and missing content.
Liaise with document owners to resolve TMF discrepancies and escalate issues to the TMF Lead when necessary.
Support TMF documentation preparation for audits, inspections, and shipments.
Maintain compliance with company standards, productivity expectations, and regulatory requirements.
Develop compliance tools, trackers, and SOP contributions to enhance TMF processes.
Provide oversight, guidance, and training to junior document management staff.
Assist in process and system improvements for clinical document management.
Ensure attention to detail, accuracy, and timely completion of all TMF-related tasks.
Required Qualifications
Bachelor’s degree in a related field or equivalent experience.
Proven experience in TMF/document management within clinical research.
Strong knowledge of GCP, ICH guidelines, and clinical regulatory requirements.
Proficiency with electronic TMF systems and clinical documentation software.
Excellent organizational, multitasking, and attention-to-detail skills.
Strong interpersonal, communication, and problem-solving abilities.
Why Join Syneos Health
Contribute to the success of global clinical trials and regulatory compliance excellence.
Work in a supportive, collaborative environment with global clinical research teams.
Access professional development, technical training, and opportunities for career progression.
Competitive benefits including medical, dental, vision, 401(k) match, Employee Stock Purchase Plan, PTO, and performance-based incentives.
Thrive in a culture that values diversity, inclusion, and employee well-being.
About Syneos Health
Partnered in the development of 94% of novel FDA-approved drugs and 95% of EMA-authorized products over the past five years.
Managed over 200 clinical studies across 73,000 sites with more than 675,000 trial participants.
Committed to innovation, quality, and global clinical excellence.
Summary:
The Senior TMF Specialist ensures the proper setup, maintenance, and closure of the Trial Master File while supporting regulatory compliance, quality review, and process improvements. Ideal candidates have strong TMF expertise, attention to detail, and experience mentoring junior staff.
Apply today to join a leading global clinical research organization and make an impact on the development of life-changing therapies.
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