Senior Director, TMF Services

TransPerfect•Princeton, NJ

6d•Hybrid

About The Position

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. 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 TMF Services division for sustained commercial growth.

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)
Outstanding verbal and written and interpersonal communication skills, with strong active listening abilities.
Strong analytical, problem-solving, and critical-thinking skills
Ability to work effectively in a global, cross-functional environment with internal and external stakeholders
Willingness to travel as required

Nice To Haves

Proven track record of business development and/or account growth in a services environment
Active involvement in industry organizations (CDISC TMF Reference Model etc.)
Experience evaluating and implementing AI/ML tools or automation within clinical workflows
Prior P&L ownership or practice management experience within a boutique or mid-size services organization

Responsibilities

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