Associate Director, TMF Operations Lead
Ladders · United States · 4 wk ago
RemoteRemoteManagement$191k–$220k/yrFull-time
Responsibilities
- Lead and oversee TMF operations to ensure inspection readiness and compliance
- Monitor TMF health, quality metrics, and communicate findings to stakeholders
- Develop and optimize TMF-related documents and processes, including SOPs and oversight plans
- Collaborate with cross-functional teams to ensure timely document management and resolve issues
- Drive CRO TMF activities through performance evaluation and continuous improvement
- Prepare for inspections through quality reviews and audit support
- Identify risks and trends in TMF compliance and implement corrective actions
Qualifications
- Minimum university degree or 8+ years of relevant experience in TMF or clinical operations
- 8+ years of experience supporting global clinical trials
- Deep understanding of the drug development life cycle and clinical trial documentation
- Strong knowledge of TMF Reference Model and compliance with ALCOA+ standards
- Excellent organizational, communication, and problem-solving skills, with attention to detail
Benefits
- Market-leading compensation
- 401(k) with employer match
- 100% employer-paid health premiums for employees and their dependents
- Flexible 'take-what-you-need' paid time off
- Comprehensive paid leave for medical and parental needs