Senior Director, TMF Services

TransPerfect is the worlds largest provider of language services and technology solutions for global business. From offices in over 160 cities on six continents TransPerfect offers a full range of services in 170 languages to clients worldwide. More than 5000 global organizations employ TransPerfects GlobalLink technology to simplify management of multilingual content. With an unparalleled commitment to quality and client service TransPerfect is fully ISO 9001 and ISO 17100 certified. TransPerfect has global headquarters in New York with regional headquarters in London and Hong Kong. For more information please visit our website at.

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 LMKs Trial Master File (TMF) services while building strong relationships across LMK TransPerfect 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 LMKs TMF Services division for sustained commercial growth.

TransPerfect Life Sciences is a leading provider of services and technologies supporting global clinical trials and product development for the biopharmaceutical industry. As part of the TransPerfect family of companies LMK Clinical Research Consulting is a recognized leader in Trial Master File (TMF) document management services and solutions. Together TransPerfect and LMK deliver comprehensive system-agnostic TMF consulting document management quality control and inspection readiness services to sponsors of all sizes. By combining decades of expertise in TMF best practices innovation and clinical operations TransPerfect and LMK help clients optimize TMF processes maintain regulatory compliance and accelerate clinical research with confidence.

• 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.

• Minimum Bachelors 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.

• 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.

At TransPerfect there are a lot of growth opportunities. All departments offer career growth and development that can combine your skills interest and experience. We encourage our employees to have a continuous dialogue with management about growth opportunities throughout your tenure with the company.

End your job search and find your career at TransPerfect #careersNOTjobs.

For more than 30 years TransPerfect has honed a culture where all kinds of ideas are shared and new ventures are not only welcomed but also this fast-paced environment employees are intellectually stimulated so they can grow alongside the organization. From Intern to President we believe that every single employee should have a voice and contribute to the amazing services we offer our clients.