Senior Director, TMF Services

Summary

The Senior Director, TMF Services is a senior leadership role responsible for the end-to-end management and strategic direction of the TMF Services division, overseeing service delivery, operational growth, and the continuous expansion of service offerings. The Senior Director will lead the strategic growth, operational excellence, and delivery of LMK’s Trial Master File (TMF) services while building strong relationships across LMK, Trans Perfect, and its global client base.

Serving as a visible market presence and internal champion, this role drives operational excellence, AI-enabled productivity, and client success across the division. The Senior Director works cross-functionally with internal stakeholders and external clients to ensure the highest standards of delivery while positioning the LMK’s TMF Services division for sustained commercial growth.

• 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 division’s 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 the 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.

• 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…