Princeton, NJ30+ days ago
10+ years of experience in Clinical Operations, Clinical Quality, RBQM, or RBM • Demonstrated experience leading enterprise or cross-study risk management frameworks • Strong background in audit/inspection readiness, CAPA management, and vendor oversight • Deep knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements. This role owns the end-to-end RBQM framework, including risk identification, assessment, mitigation, centralized monitoring, lessons learned, and maintenance of a clinical risk library, ensuring risks are managed consistently and intelligently across studies, programs, vendors, and regions.