Senior Director, TMF Services

This is a fully remote position, open to applicants in New Jersey, +2 more states.

📋 Description

• Collaborate with executive leadership to formulate annual business strategies, revenue objectives, and service line plans.

• Assist in business development efforts to discover, pursue, and secure new business opportunities, including new client partnerships, expanded project scopes, and strategic alliances.

• Hold Profit & Loss (P&L) responsibility for the divisions TMF Services practice, enhancing profitability through effective delivery methods and pricing strategies.

• Continuously assess and implement top-tier tools and workflows for eTMF management, TMF record quality, and readiness for inspections.

• Create scalable delivery models and quality benchmarks across client projects.

• Track industry trends (regulatory updates, technological advancements, competitive landscape) and convert insights into service enhancements.

• Revise, implement, and oversee departmental adherence to Standard Operating Procedures (SOPs).

• Advocate for the integration of AI technologies, automation, and digital solutions to improve team efficiency and client results.

• Act as an executive sponsor for significant client accounts, ensuring high levels of satisfaction, retention, and growth.

• Supervise the effective delivery of the TMF Services portfolio, ensuring projects adhere to quality, timelines, budgets, and compliance requirements.

• Cultivate trusted advisor relationships with client stakeholders at the director and C-suite levels.

• Ensure team members achieve departmental and project productivity and quality standards through efficient execution of their projects according to the project plan.

• Serve as a prominent spokesperson and subject matter expert for the company in the eTMF and clinical operations domain.

• Represent the organization as a thought leader and subject matter expert at industry conferences, through publications, webinars, and professional networks.

• Establish and maintain a robust external network with sponsors, CROs, technology providers, and industry organizations.

• Recruit, develop, and lead a high-performing team while promoting a culture of accountability, collaboration, and continuous improvement.

• Work collaboratively across commercial, technology, and operational teams to meet strategic business goals.

• Perform all other tasks deemed suitable for the role as assigned by the manager or supervisor.

⛳️ Requirements

• A minimum of a Bachelor's degree or equivalent in life sciences, health sciences, or a related area.

• At least 12 years of progressive experience in clinical operations, TMF, or clinical records management within a CRO, sponsor company, or clinical services provider.

• A minimum of 10 years of supervisory or management experience.

• Strong comprehension of clinical trial processes and clinical records management operations.

• Proven experience in presenting, speaking, or publishing in industry forums and professional environments.

• Demonstrated success in leading and scaling teams in dynamic, client-facing settings.

• Established 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 relevant regulations and guidelines: ICH E6(R2/R3), FDA 21 CFR Part 11, EMA TMF guidelines, CDISC TMF Reference Model.

• Solid understanding of drug development and clinical trial operations.

• Proven capability to navigate ambiguity and effectively build and scale processes, teams, and service offerings.

• Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).

• Exceptional verbal, written, and interpersonal communication skills, along with strong active listening abilities.

• Strong analytical, problem-solving, and critical-thinking skills.

• Ability to work efficiently in a global, cross-functional environment with both internal and external stakeholders.

• Willingness to travel as needed.

🏝️ Benefits

• Opportunities for career advancement.

• A collaborative environment where ideas are encouraged.

• Support for ongoing dialogue with management.