Associate Director, TMF Management

Role Overview

• 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

Requirements

• 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

Tech Stack

• Google Cloud Platform
• Vault

Benefits

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
• Commitment to growing you professionally and providing access to resources to further your development
• Apogee offers regular all team, in-person meetings to build relationships and problem solve