Associate Director, Clinical Operations

Lead global clinical studies from early-stage development, ensuring delivery against timeline, budget, and quality expectations while providing strategic oversight of CROs and vendors. Develop and review study performance metrics, drive corrective actions, and evaluate site trends to mitigate risks. Serve as the Clinical Operations representative on Strategy Teams, coordinate team meetings, and update cross-functional stakeholders on timelines and milestones. Contribute to study documentation including protocol review, creating study manuals, ICFs, and designing CRFs. Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning and listing review. Perform clinical research site activities such as onsite or remote monitoring, co-monitoring, training, and sponsor oversight visits. Ensure study documentation adheres to applicable regulations, industry standards, and SOPs. Collaborate with Clinical, Regulatory, and Quality teams to ensure compliance with FDA regulations, ICH GCP, and company policies. Limited travel possible to clinical sites for investigator and site engagement, with potential to travel (~25%).