Associate Director Clinical Operations

Responsibilities:

The Associate Director, Site and Monitoring Health Team Lead will provide strong leadership, GCP expertise and clinical operations experience to drive the monitoring strategy for trials in their assigned program(s). They are responsible for co-directing (in a matrix environment) the extended team to safeguard the quality of clinical trial execution at investigator sites and ensure Alnylam's oversight of CRO monitoring effectiveness. The Associate Director, Site and Monitoring Health Team Lead will line manage and matrix manage Site and Monitoring Health Regional Leads (SMH Regional Leads) and direct the work of FSP Site and Monitoring Health Leads. This position reports to the Director, Clinical Operations - Site and Monitoring Health (Global).

Summary of Key Responsibilities:

• Develop, implement, and oversee Alnylam's Site and Monitoring Health strategy in alignment with ICH GCP E6 and E8, ensuring that monitoring plans for trials assigned reflect the strategy and the trial budget is aligned.
• Lead, direct, and support Site and Monitoring Health Regional Leads in assessing CRO monitoring effectiveness across the portfolio.
• Direct day-to-day work activities for FSP Vendor Site and Monitoring Health Leads
• Liaise with CRO partners and internal partners (including Clinical Risk & Analytics and Study Management) to ensure overall understanding of monitoring strategy and alignment among trial plans.
• Consistently manage oversight activities at the program level as aligned and ensure Study Specific Oversight Plans are appropriately implemented and followed for all studies within scope.
• Drive a culture that balances purposeful urgency with passion for excellence, employ risk-based thinking to focus on what is critical to quality, and emphasize an "inspection ready at all times" mentality.
• Develop and maintain effective working relationships with stakeholder functions to achieve Clinical Operations' goals.
• Assist in planning and trial optimization to evolve the Clinical Operations organization as we scale for the future.
• Participate in various workstreams and projects as a leader in Clinical Operations to improve and refine processes.
• Ensure Site and Monitoring Health Regional Leads complete administrative tasks on time and facilitate their continuous development.
• Determine resourcing needs within Site and Monitoring Health and workload allocation based on the portfolio.
• Support inspection preparation and management.
• Maintain awareness of changes in industry and regulatory standards for GCP requirements and share updates with Site and Monitoring Health Team
• Travel (including occasional global travel) averages