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 roadmap.

• Assist in business development efforts to identify, pursue, and secure new business prospects, including new client partnerships, expanded scopes of work, and strategic alliances.

• Assume Profit & Loss (P&L) responsibility for the divisions TMF Services practice, enhancing profitability through effective delivery models 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 frameworks and quality benchmarks across client projects.

• Track industry trends (regulatory guidelines, technology 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 tools to boost team efficiency and client results.

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

• Supervise the effective delivery of the TMF Services portfolio, ensuring that projects fulfill quality, timeline, budget, and compliance goals.

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

• Ensure team members achieve departmental and project productivity and quality benchmarks through efficient project execution in alignment with the project plan.

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

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

• Establish and maintain a robust external network with sponsors, CROs, technology vendors, and industry associations.

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

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

• Complete all other tasks deemed suitable for the role as assigned by the manager/supervisor.

⛳️ Requirements

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

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

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

• Proven track record of presenting, speaking, or publishing in industry forums and professional environments.

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

• Proven expertise in Trial Master File (TMF) strategy, eTMF platforms (e.g., Veeva Vault, TI, Wingspan, Medidata, etc.), and ensuring TMF inspection readiness.

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

• Strong understanding of drug development processes and clinical trial operations.

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

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

🏝️ Benefits

• Opportunities for career growth and professional development.