Associate Director, TMF Operations Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee TMF operations for assigned clinical studies, guaranteeing timely, complete, and inspection-ready Trial Master File documentation in line with ICH-GCP, regulatory requirements, and company standards.

• Implement TMF governance throughout the clinical development program by assessing TMF health, quality metrics, risk evaluations, and inspection readiness, while conveying critical insights to study teams and leadership.

• Create, sustain, and continually enhance TMF processes and governing documents, including TMF Plans, TMF Indexes, SOPs, guidance documents, and CRO TMF Oversight Plans.

• Collaborate with Clinical Operations, Regulatory, Data Management, Medical Writing, Quality Assurance, and external vendors to ensure prompt document filing, issue resolution, and uniform application of TMF processes.

• Provide strategic oversight of CRO-managed TMF activities by utilizing performance metrics, governance meetings, quality reviews, issue escalation, and initiatives aimed at continuous improvement.

• Direct TMF inspection readiness efforts, including ongoing quality reviews, health assessments, audit support, inspection preparation, artifact retrieval, and the development and follow-up of CAPAs.

• Recognize TMF compliance risks and quality trends, formulate mitigation strategies, and propel corrective and preventive actions to uphold a state of continuous inspection readiness.

• Act as the TMF Subject Matter Expert by offering strategic guidance, delivering training, mentoring study teams, and representing TMF Operations in cross-functional initiatives.

• Evaluate TMF performance metrics and vendor quality outputs to identify trends, suggest process enhancements, and bolster operational effectiveness across the development program.

• Cultivate a culture of TMF excellence through knowledge sharing, lessons learned, and the adoption of innovative strategies to enhance TMF quality and efficiency.

⛳️ Requirements

• Minimum educational requirement: University degree or equivalent professional education, preferably in medicine/science, paramedical science, computer science, business management, or a related field, or over 8 years of extensive experience in similar roles with a proven track record; direct industry experience may be accepted in lieu of education.

• 8+ years of experience in TMF Operations, Clinical Operations, or Clinical Quality, with a background in supporting global clinical trials.

• Comprehension of the drug development life cycle.

• Experience in managing clinical trial-related documents is essential.

• Strong knowledge of the Trial Master File Reference Model Structure standard and country-specific documents.

• Proven ability to understand and adhere to ALCOA+ standards, ICH-GCP guidelines, and Good Documentation Practices.

• Demonstrated capacity to meet high-performance goals and deadlines in a fast-paced setting.

• Exceptional organizational skills, maintaining high standards and meticulous attention to detail.

• Strong verbal and written communication skills.

• Highly diligent and proactive in efficiently resolving issues.

• Must be resourceful and adaptable to manage multiple competing demands and shifting priorities.

• Proven success in problem-solving, strong decision-making, critical thinking, and conflict management.

• Proficient in Microsoft Excel, Word, and PowerPoint, with familiarity in Smartsheet and SharePoint.

🏝️ Benefits

• Market-leading compensation.

• 401(k) with employer match.

• Employee Stock Purchase Program (ESPP).

• Pre-tax commuter benefits (transit and parking).

• Referral bonus for hired candidates.

• Subsidized lunch and parking on in-office days.

• 100% employer-paid medical, dental, and vision premiums for you and your dependents.

• Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA).

• Fertility and family-forming benefits.

• Expanded mental health support (therapy and coaching resources).

• Hybrid work model with flexibility.

• Flexible, “take-what-you-need” paid time off and company-paid holidays.

• Comprehensive paid medical and parental leave to care for yourself and your family.