Manager Clinical Study Lead

Responsibilities

• Lead global execution of assigned clinical trials from design through closeout, managing timelines, budgets, and regulatory compliance
• Oversee cross-functional study teams, site selection, investigator meetings, and study documentation development
• Manage vendor engagement and CRO relationships; ensure alignment with scope of work and contractual obligations
• Lead study risk assessment, patient recruitment strategies, and data monitoring; address deviations from plan
• Supervise Clinical Study Management staff; drive process improvements and study closeout activities including database lock and lessons learned

Requirements

• Bachelor's degree and six years of clinical trial operations experience
• Extensive budget management expertise and vendor management experience
• Technical proficiency with trial management systems, IVRS/IWRS, EDC, and Microsoft Office
• Knowledge of ICH/GCP guidelines, regulatory requirements, and protocol development
• Strong project management, cross-functional leadership, and organizational skills