Associate Director, Clinical Operations

Responsibilities

• Serve as the clinical operations lead for one or more global clinical studies, ensuring delivery of study objectives on timeline, budget, and quality expectations.
• Provide strategic oversight of CROs and vendors, ensuring accountability, quality, and operational execution.
• Develop and review study performance metrics and drive corrective and preventive actions when needed.
• Evaluate and analyze site trends, evaluate study risks and mitigation strategies, and work with the cross-functional team in the review clinical data.
• Develop strong partnerships with external stakeholders while maintaining sponsor ownership of study execution.
• Serve as Clinical Operations representative on Strategy Teams, and coordinate and lead study team meetings and update the cross-functional Team on timelines and milestones for the study.
• Contribute to the development of study documentation including protocol review, creating study manuals, ICFs, designing CRFs, and ensure proper team and external training.
• Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing.
• Support the evaluation of study vendors, including negotiation of contracts and budgets with CROs, clinical sites and vendors.
• Perform clinical research site activities, such as onsite or remote monitoring, co-monitoring, training, motivational, and sponsor oversight visits, as needed.
• Ensure that study documentation is maintained according to applicable regulations, industry accepted standards, and SOPs that govern clinical studies both in the field and in-house.
• Collaborate with Clinical, Regulatory, and Quality team members to ensure compliance of department/study activities with FDA regulations, guidelines, and principles of ICH GCP and company SOPs.

Qualifications

• BS/BA Degree or equivalent in science or a health-related field is preferred.
• Minimum 6-7+ years of relevant industry clinical development experience.
• Experience with complex therapeutic platforms and multi-phase clinical trials.
• Experience with all aspects of trial and site startup and vendor selection and management, study management, and monitoring.
• Familiarity with clinical data review and data management processes.
• Excellent knowledge of GCP, ICH, and FDA regulations.
• Experience with SOP review and development.