Senior TMF Specialist | Remote – New Jersey, USA
Location: New Jersey, USA (Remote)
Job ID: 25104073
Updated: December 3, 2025
Overview
Syneos Health® is a leading global biopharmaceutical solutions organization dedicated to accelerating clinical development and improving patient outcomes. We are seeking a Senior Trial Master File (TMF) Specialist to join our remote team in New Jersey.
The ideal candidate will have experience managing TMF repositories, ensuring regulatory compliance, and supporting clinical trial documentation in accordance with GCP, ICH guidelines, and study-specific requirements. This role also includes mentoring junior document management staff and contributing to process optimization.
Key Responsibilities
Manage, maintain, and close TMF repositories for clinical trials in compliance with SOPs, WIs, GCP, ICH guidelines, and study-specific processes.
Collect, scan, index, and quality review study documentation within an electronic TMF system.
Perform completeness reviews against Expected Document Lists (EDLs) and identify missing or non-compliant documents.
Liaise with document owners to resolve discrepancies and escalate issues to the TMF Lead when necessary.
Support TMF documentation preparation for audits, inspections, and shipments.
Develop and implement compliance tools, trackers, and SOP contributions to improve TMF processes.
Provide oversight, guidance, and training to junior document management team members.
Maintain high levels of accuracy, attention to detail, and productivity while multitasking across projects.
Collaborate with Line Manager and study teams to implement TMF best practices.
Required Qualifications
Bachelor’s degree in a related field or equivalent combination of education and experience.
Prior experience in TMF/document management within clinical research.
Knowledge of GCP, ICH guidelines, and applicable regulatory requirements.
Proficiency with electronic TMF systems and clinical document management tools.
Strong organizational, multitasking, and problem-solving skills.
Excellent communication and interpersonal abilities.
Why Join Syneos Health
Contribute to the success of global clinical trials and regulatory compliance excellence.
Work remotely in a collaborative environment with cross-functional global teams.
Access professional development, technical training, and career advancement opportunities.
Competitive benefits including medical, dental, vision, 401(k) match, Employee Stock Purchase Plan, flexible PTO, and performance-based incentives.
Thrive in an inclusive, diverse culture that values employee well-being and professional growth.
About Syneos Health
Supported 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 Trial Master Files while supporting regulatory compliance, quality review, and process improvements. Ideal candidates are detail-oriented, experienced in TMF management, and capable of mentoring junior staff.
Apply now to join a leading global clinical research organization and make an impact on the development of life-changing therapies.
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