Clinnect · 22 hours ago
Senior TMF Specialist
United States
Full-time
Remote
Senior Level
5+ years expClinnect is a company focused on clinical trials, and they are seeking a Senior Trial Master File (TMF) Specialist to oversee the quality and regulatory compliance of the Trial Master File. This role involves partnering with internal teams and external service providers to ensure documentation meets inspection standards and supports continuous improvement of TMF-related processes.
Staffing & Recruiting
Responsibilities
Review eTMF content to assess document quality, accuracy, and completeness, identifying gaps and driving timely resolution
Maintain and reconcile Expected Document Lists (EDLs), confirming required records are present, appropriately filed, and up to date
Evaluate findings from TMF reviews to identify recurring issues, emerging risks, and opportunities for process enhancement
Prepare and maintain metrics, reports, and dashboards to monitor TMF health, completeness, and compliance status
Analyze metadata and submission patterns to detect inefficiencies, delays, or compliance risks within TMF workflows
Act as the primary point of contact between internal study teams and CRO TMF representatives to ensure alignment on expectations, processes, and issue resolution
Support audit and inspection readiness activities by ensuring TMF content is well-organized, current, and readily retrievable
Provide guidance and training to study team members on TMF standards, best practices, and system use as needed
Collaborate with cross-functional stakeholders to ensure adherence to TMF governance models and evolving regulatory expectations
Qualification
Required
Bachelor's degree in a scientific, technical, or related discipline
Minimum of 5 years of experience supporting TMF quality and oversight within a clinical research, pharmaceutical, or biotechnology environment
Hands-on experience with electronic TMF systems (e.g., Veeva Vault or comparable platforms)
Strong working knowledge of the TMF Reference Model, ALCOA+ principles, and global regulatory standards, including ICH-GCP and ICH E6 (R3)
Demonstrated ability to interpret regulatory requirements and apply them pragmatically to TMF operations
Experience developing and interpreting TMF metrics, reports, and dashboards
Strong analytical skills with a high level of attention to detail and follow-through
Effective communicator with the ability to collaborate across functions and with external partners
Prior involvement in audit preparation, regulatory inspections, and TMF document retrieval
Proficiency with standard office applications (Excel, Word, PowerPoint, Outlook)
Company
Clinnect
Clinnect brings together the best talent for biotechnology, pharmaceutical, medical device, and CRO companies across the US.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
Taylor McCarthy
Co-Founder
Company data provided by crunchbase