Manager Central Monitoring
Pharma
Job description
Build our future together: Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health. At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, Central Monitoring, Data Analysis to join our Global Clinical Trial Services team. In this role, you will oversee centralized monitoring activities for global and complex clinical trials and support the configuration, execution, and maintenance of Risk-Based Quality Management (RBQM) platforms. You will leverage your programming and analytical expertise to create customized analyses, automate workflows, integrate data systems, and deliver actionable insights that support informed decision-making and optimize clinical trial performance. You may also 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 . When & where: Hyderabad, India (hybrid) Discover your role: Act as a subject-matter expert for the configuration, implementation, and execution of Central Monitoring RBQM platforms across studies. Maintain Regeneron Central Monitoring Key Risk Indicator and Quality Tolerance Limit libraries to ensure consistent deployment across studies and alignment with regulatory requirements. Configure studies within an RBQM platform by partnering with functional and cross-functional stakeholders to develop Central Monitoring configuration specifications. Provide operational expertise, training, and guidance, serving as an escalation point for issues related to the Central Monitoring RBQM platform. Conduct central monitoring reviews as required, including recurring data refreshes and troubleshooting execution errors in support of Study Central Monitors. Apply programming expertise to support Central Monitoring data analysis, automation, reporting, and system integration. Interpret and present Key Risk Indicator and Key Performance Indicator data to support informed decision-making. Contribute to the continuous improvement and standardization of technologies, systems, processes, and training materials that support Central Monitoring and RBQM. Represent Central Monitoring in process-improvement initiatives and collaborate effectively with internal and external stakeholders. Oversee multiple studies within an assigned therapeutic area, as applicable, and contribute to innovation in central monitoring capabilities. Travel up to 25%, as required. This role requires: At least 7 years of relevant biotechnology or pharmaceutical industry experience. Experience in Central Monitoring, site monitoring, or data management is preferred. A minimum of 2 years of direct experience with RBQM systems. Technical expertise in database design, system configuration, and report development, with experience managing RBQM or similar platfor
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