Jobs / India / Regeneron Pharmaceuticals INC
Manager, Local Lab Delivery
Regeneron Pharmaceuticals INC · 🌍 Hyderabad
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About the role
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, Local Lab Delivery to lead the operational delivery, oversight, and continuous improvement of local laboratory reference range data management supporting our clinical development portfolio. In this role, you will oversee the end-to-end local laboratory data process, ensuring reference ranges, units, conversion factors, analyse mappings, and associated metadata are accurately interpreted, quality controlled, maintained, and configured within laboratory management systems. You will also lead and develop a team of Local Lab Delivery Specialists and collaborate across Clinical Data Management, Clinical Operations, study teams, technology teams, and external partners. When & where: Hyderabad (hybrid) Discover your role: • Lead the operational delivery of local laboratory data activities across clinical studies, ensuring timely execution, quality oversight, issue resolution, and effective study support. • Oversee the intake, interpretation, quality control, maintenance, and delivery of local laboratory reference ranges and metadata, including units, conversion factors, analyse mappings, and study-specific configurations. • Ensure accurate and timely configuration, maintenance, and quality oversight of local laboratory information within the EDC Lab Administration system. • Provide consultation and guidance on study-specific local laboratory setup requirements, metadata, and complex local laboratory data issues. • Oversee the maintenance, harmonization, and reuse of local laboratory metadata assets, including analyte libraries, laboratory templates, analyte mappings, units of measure, and reference range information. • Serve as the escalation point for complex local laboratory data issues and lead root cause analysis, CAPA development, issue resolution, and process remediation activities. • Partner with Clinical Data Management, Clinical Operations, study teams, system owners, technology teams, laboratory vendors, and external partners to drive successful local laboratory delivery. • Establish and monitor turnaround times, operational targets, and quality metrics supporting study startup, ongoing data management activities, and database lock achievements. • Ensure local laboratory data processes, systems, and documentation comply with SOPs, work instructions, quality standards, GxP requirements, and inspection-readiness expectations. • Drive continuous improvement and technology enablement, including opportunities involving automation, AI-enabled solutions, document extraction, unit harmonization, metadata classification, test synonym mapping, and quality review. • Lead, coach, mentor, and develop a team of Local Lab Delivery Specialists while managing performance objectives, development plans, workload allocation, resource planning, and operational priorities. This role requires: • Bachelor’s degree in Science, Health, Data Management, Mathematics, Computing, or a related field. • 7+ years of Clinical Data Management experience within biotechnology, pharmaceutical, CRO, or healthcare environments. • 5+ years of direct Local Laboratory Delivery experience and 2+ years of people management experience. • Advanced knowledge of local labora