Associate Director, TMF Management

Role Summary

We are seeking an Associate Director of TMF (Trial Master File) Management. This position is responsible for the oversight, planning, resourcing, and execution of end-to-end TMF management processes from start up through archival and for ensuring optimal health of TMF content from both external and internal sources. In this role you will provide technical and operational leadership, strategic direction, and ensure continuous inspection readiness. You will apply cross-functional collaboration to drive change management, promotion adoption of enhanced processes and standards, foster a culture of continuous improvement, and ensure proper implementation, execution, and alignment with companies’ goals, culture, and vision. Additionally, you will  assist with developing and implementing TMF processes, SOPs, supporting tools, templates, and training. You will have the opportunity to lead a team who manage the TMF for studies in the program. This position will oversee TMF vendors and work with the IT group to support implementation, ongoing maintenance, and configuration changes of the eTMF platform in alignment with the business requirements.

Key Responsibilities

• Provide leadership and act as a Subject Matter Expert (SME) for TMF operations and requirements across study team functions, CROs, and vendors to ensure TMF content is timely, complete, and of the highest quality for in-house and outsourced studies
• Build and maintain collaborative relationships with cross-functional partners, CROs, and external vendors to ensure expectations are clear, deliverables are met, and issues are resolved in a timely manner
• Serve as an escalation point for study teams to drive resolution of issues, as appropriate
• Ensure compliance with TMF Management SOPs, Good Documentation Practices (GDocP), ALCOA-CCEA principles (i.e. records must be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring & Available), applicable regulations, GCP requirements, and industry standards
• Monitor and report KPIs to senior management, identifying trends across the portfolio, areas for improvement, and implementing changes as needed
• Identify root cause of performance issues, determine the appropriate remediation, and implement solutions as required
• Responsible for the management and leadership of a team of direct reports that will support the eTMF platforms and each study TMF including recruitment, training, mentoring, career development, work assignments, performance evaluations, and ongoing feedback
• Assist with development and implementation of TMF processes, procedures, supporting tools, and TMF-related training materials that adhere to regulatory requirements and industry best practices
• Review external TMF-related SOPs and associated documentation as needed
• Author and review TMF Plans and associated documentation (e.g., TMF indexes/mapping, risk-based QC processes etc.), working with the cross functional study team to obtain necessary input
• Oversee study teams in TMF closeout activities, including collection of study records from all vendors, end of trial TMF QC, and migration activities, if applicable
• Oversee archiving activities to ensure adherence to processes and industry best practices
• Ad hoc support of activities within the Clinical Operations team to help meet timelines and objectives including support with start-up activities, record collection and processing, QC, and/or archiving, as needed
• Collaborate on projects with Information Technology (IT) to ensure effective implementation and integration of eTMF clinical systems
• Lead and manage resolution of issues and remediation activities with stakeholders and the eTMF vendor
• Serve as eTMF Business Owner and Administrator

• Support integration of partnered or clinical information including TMF transfers in compliance with applicable regulations and best practice
• Provide eTMF system training and acts as a primary support for users and study teams
• Assist management with identifying areas of improvement and enhancements and obtains approval for system development projects

Ideal Candidate

• Bachelor's Degree or higher
• 10+ years of experience successfully leading the TMF activities for clinical research/ biotech/pharmaceutical
• Experience with Veeva Vault eTMF platform, strongly preferred
• Experience with implementation and integration of eTMF platforms
• Experience with computer system validation/assurance
• Experience in managing direct reports and leading teams to execute projects
• Knowledge of the principles and practices of traditional records management as applied to the pharmaceutical/ biotech or contract research organization industry

• Comprehensive knowledge of TMF Reference Model, regulations, Good Clinical Practices (GCP), and ICH Guidelines
• Strong software and computer skills, including Microsoft Office applications (Outlook, Word, Excel & PowerPoint)
• Relevant experience in processing, archiving, and retrieving records in electronic format
• Experience with writing and revising SOPs related to eTMF systems
• Knowledge of relevant licensing and industry compliance regulations
• This role necessitates self-direction, motivation, problem solving and decision-making abilities
• Demonstrated effective written and verbal communication skills with internal and external team members, and functional leadership
• Able to lead initiatives and communicate effectively through presentations for external and internal audiences
• Excellent organizational skills with outstanding attention to detail and follow through
• Able to successfully manage/prioritize multiple projects with limited direction from manager
• Able to navigate complex problems, develop advanced concepts, make decisions, anticipate challenges, and propose solutions/recommendations   
• Able to collaborate with the vendor on on-going system issues, upgrades, and maintenance
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Position requires up to 10% travel including mandatory in-person attendance at All Hands Meetings typically held twice per year

The anticipated salary range for candidates for this role will be $170,000 - $185,000 per 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.