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 goals, and the service line roadmap.

• Assist in business development efforts to discover, pursue, and secure new business opportunities, including establishing new client relationships, expanding scopes of work, and forming strategic partnerships.

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

• Regularly assess and apply best-in-class tools and workflows for eTMF management, ensuring TMF record quality and inspection readiness.

• Create scalable delivery frameworks and quality standards across client engagements.

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

• Revise, implement, and oversee departmental compliance with Standard Operating Procedures (SOPs).

• Advocate for the integration of AI technologies, automation, and digital tools to boost team productivity and improve client outcomes.

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

• Supervise the effective delivery of the TMF Services portfolio, ensuring projects align with 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 metrics through the efficient execution of their projects in accordance with the project plan.

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

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

• Establish and nurture a strong external network with sponsors, CROs, technology vendors, and industry associations.

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

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

• Carry out any additional tasks deemed appropriate 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 settings.

• Demonstrated success in leading and scaling teams in fast-paced, client-facing environments.

• Extensive 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 trials operations.

• Proven ability to navigate uncertainty and successfully develop and scale processes, teams, and service offerings.

• Proficient 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 capabilities.

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

• Willingness to travel as needed.

🏝️ Benefits

• Health insurance.

• Retirement plans.

• Paid time off.

• Flexible work arrangements.

• Professional development.