Manager Central Monitoring

ROLE OVERVIEW

## Job Description ### Build our future together Regeneron develops and commercializes medicines for serious diseases through science and innovation across drug development, manufacturing, and commercialization. ### Your Role The Manager, Central Monitoring, Data Analysis will join the Global Clinical Trial Services team in Hyderabad. The role oversees centralized monitoring activities for global and complex clinical trials and supports configuration, execution, and maintenance of Risk-Based Quality Management (RBQM) platforms. The position combines programming, data analysis, workflow automation, data-system integration, and clinical trial risk management. The role may oversee multiple studies within an assigned therapeutic area, lead process-improvement initiatives, and collaborate with cross-functional teams and industry partners to advance central monitoring capabilities. ### Discover Your Role - Act as a subject-matter expert for Central Monitoring RBQM platform configuration, implementation, and execution. - Maintain Central Monitoring Key Risk Indicator and Quality Tolerance Limit libraries. - Configure studies and develop Central Monitoring configuration specifications with stakeholders. - Provide operational expertise, training, guidance, and escalation support. - Conduct central monitoring reviews, data refreshes, and troubleshooting. - Apply programming expertise to data analysis, automation, reporting, and system integration. - Interpret KRI and KPI data to support decision-making. - Contribute to technology, system, process, and training standardization. - Represent Central Monitoring in process-improvement initiatives. - Oversee multiple studies within an assigned therapeutic area where applicable. - Travel up to 25% as required. ### Requirements At least 7 years of relevant biotechnology or pharmaceutical industry experience and at least 2 years of direct RBQM systems experience are required. The role requires database design, system configuration, report development, programming, clinical development knowledge, ICH/GCP knowledge, clinical database and EDC experience, analytical skills, and strong communication. CluePoints or similar centralized monitoring/RBQM experience is preferred.