Senior Director, Head of Trial Master File (TMF)

We are seeking a Senior Director of TMF to serve as the Head of Trial Master File (TMF) Operations.  This position is responsible for the oversight, creation, strategy, planning, resourcing, and execution of a TMF document management system for the clinical operations department.  This position is responsible for cross-functional collaboration to ensure proper implementation, execution and alignment with companies’ goals, culture, and vision. This role is accountable to develop document collection strategies and develop SOPs, training, and overall process to ensure the TMF health and archival of clinical trial documents from both external and internal sources. The position is responsible for direct reports to manage the TMF and continue to work with IT in the evaluation, and implementation of any additional technology and vendors to support documentation and training solutions for inspection readiness.  

Key Responsibilities 

• Provide leadership and strategic direction across Clinical Operations and study team functions to ensure the Trial Master File (TMF) processes and related documentations are of the highest quality for active in-house and outsourced studies by drawing experience w/ quality compliance processes and regulations such as Good Clinical & Documentation Practices 
• Adhere to ALCOA-CCEA principles (i.e. records must be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring & Available) 
• Develop standard reporting for ongoing compliance check by study to be presented at the Clinical study team meetings and to management 
• Lead a team of direct reports that will support the TMF platforms and each study TMF 
• Author and review internal and external TMF-related SOPs, work instruction development and procedural documents as well as TMF Plans and associated documentation (e.g., TMF indexes/mapping, risk-based QC processes etc.) including working with the cross functional study team to obtain necessary input 
• Manage the TMF processes to meet the goals and objectives of the department and maintains inspection readiness for all active studies  
• Create and lead training across all relevant business units/functional areas on business processes around Clinical Document Management and the Trial Master File, eTMF system(s), and quality oversight of vendors  
• Development and oversight of management and maintenance of TMF repositories, including supporting filing, scanning, QC, and inventory of paper documents 
• Partner with IT and internal clinical business operations resources to support the strategic lifecycle of TMF including, but not limited to, version releases, system updates, validation or user acceptance testing, and integrations with other clinical applications through change management  
• Support study teams in end of trial eTMF QC and migration activities, including study documents from all vendors
• Drive the development and reporting of metrics and KPIs related to inspection readiness, quality, TMF completeness, and performance  
• Ad hoc support of activities within the Clinical Operations team to help meet timelines and objectives including support with archiving, document collection and processing, and/or start-up activities as needed
• Apply knowledge of ICH-GCP, Code of Federal Regulations (CFR), and other national and local requirements to develop and improve document management processes  

Ideal Candidate 

• Bachelor's Degree or higher  
• 15+ years' experience leading successfully the TMF activities for clinical research/ biotech/pharmaceutical 
• Leadership skills and experience managing employees and contractors  
• Experience with Veeva eTMF platform, strongly preferred 
• Experience with Trial Master File Reference model and good understanding of records management best practices  
• Knowledge of applicable TMF and Document Management regulations and guidelines such as CFR Part 11, MHRA and EMA 
• Experience with Inspection readiness 
• Hands on experience in a regulatory body inspection, strongly preferred 
• Thorough knowledge of ICH-GCP guidelines and applicability to all stages of the clinical development process  

 
BEHAVIORAL COMPETENCIES 

• Excellent attention to accuracy and details  
• Effective written and verbal communication skills  
• Excellent presentation skills, providing information to a large audience  
• Strong software and computer skills, including Microsoft Office applications (Word, Excel, Outlook) 
• Outstanding organizational skills with the ability to multi-task and prioritize in a fast-paced environment  
• Ability to learn new technologies with ease  
• Solid analytical and proactive problem-solving skills  
• Strong operational skills and demonstrated ability to meet timelines  
• A team player with ability to build relationships at all levels  
• Demonstrated self-starter with a high level of commitment   

The anticipated salary range for candidates for this role will be $250,000-$280,000/year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.