Senior Director, TMF Services

Role Overview

• Partner with executive leadership to develop annual business plans, revenue targets, and service line roadmap
• Support business development to identify, pursue, and close new business opportunities including new client relationships, expanded scopes of work, and strategic partnerships
• Own Profit & Loss (P&L) accountability for the divisions TMF Services practice, driving profitability through efficient delivery models and pricing strategy
• Continuously evaluate and implement best-in-class tools and workflows for eTMF management, TMF record quality, and inspection readiness
• Establish scalable delivery frameworks and quality standards across client engagements
• Monitor industry trends (regulatory guidance, technology evolution, competitive landscape) and translate insights into service improvements
• Revise, implement and monitor departmental compliance with SOPs
• Champion the adoption of AI technologies, automation, and digital tools to enhance team productivity and client outcomes
• Serve as an executive sponsor for key client accounts, ensuring high levels of satisfaction, retention, and growth
• Oversee the successful delivery of the TMF Services portfolio, ensuring projects meet quality, timeline, budget, and compliance objectives
• Build trusted advisor relationships with client stakeholders at the director and C-suite level
• Ensure team members meet departmental and project productivity and quality metrics by efficient execution of their project in line with project plan
• Serve as a visible spokesperson and subject matter expert for the company in the eTMF and clinical operations space
• Represent the organization as a thought leader and subject matter expert through industry conferences, publications, webinars, and professional networks.
• Build and maintain a strong external network with sponsors, CROs, technology vendors, and industry associations
• Recruit, develop, and lead a high-performing team while fostering a culture of accountability, collaboration, and continuous improvement
• Collaborate cross-functionally with commercial, technology, and operational teams to achieve strategic business objectives · Complete all other tasks deemed appropriate for the role as assigned by the manager/supervisor

Requirements

• Minimum Bachelor's degree or equivalent in life sciences, health sciences, or related field
• At least 12 years of progressive experience in clinical operations, TMF, or clinical records management within a CRO, sponsor company, or clinical services provider
• Minimum of 10 years of supervisory/management experience
• Strong understanding of clinical trial processes and clinical records management operations
• Proven experience presenting, speaking, or publishing in industry forums and professional settings
• Demonstrated success in leading and scaling teams in fast-paced, client-facing environments
• Demonstrated expertise in Trial Master File (TMF) strategy, eTMF platforms (e.g., Veeva Vault, TI, Wingspan, Medidata etc.), and supporting TMF inspection readiness
• Strong knowledge of applicable regulations and guidance: ICH E6(R2/R3), FDA 21 CFR Part 11, EMA TMF guidelines, CDISC TMF Reference Model
• Strong understanding of drug development and clinical trials operations
• Proven ability to navigate ambiguity and successfully build and scale processes, teams, and service offerings.
• Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint)

Tech Stack

• Vault

Benefits

• Career growth and development opportunities