Jobs / India / Regeneron Pharmaceuticals INC
Manager, External Data Acquisition and 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. We are seeking a Manager, External Data Acquisition and Delivery to join our Clinical Data Management team in a hybrid role. In this role, you will lead external data acquisition, delivery, and reconciliation activities across assigned Clinical Development Units, ensuring high-quality and compliant external data management practices. You will be responsible for the development of medium to high complexity Data Transfer Specifications (DTS), handle vendor oversight activities, support inspection readiness, and partner with CROs, external data providers, and cross-functional stakeholders to ensure timely and accurate delivery of external clinical data. This position offers the opportunity to drive data integrity, enhance operational perfection, and support successful study execution in a fast-growing, science-driven organization making a meaningful difference to patients worldwide. When & where: Hyderabad (Hybrid) Discover your role: • Lead the development, maintenance, and governance of Data Transfer Specifications (DTS) for assigned studies and Clinical Development Units. • Author DTS documents in alignment with CDISC standards and Regeneron processes while collaborating with internal and external partners. • Act as a key liaison between Clinical Data Management, CROs, external vendors, and study teams to ensure successful external data delivery. • Provide oversight for external data vendors, including onboarding, performance monitoring, issue resolution, and escalation management. • Track DTS milestones, results, and timelines across multiple programs and data domains. • Support protocol reviews, vendor specifications, operational data flows, and data structure requirements. • Perform and supervise reconciliation between EDC and vendor data systems to ensure data integrity, completeness, and consistency. • Collaborate with Database Development, Biostatistics, Data Managers, and external partners to investigate and resolve data discrepancies. • Monitor data trends, identify risks, and support continuous improvement initiatives across External Data Services. • Support inspection readiness activities, reconciliation documentation, audit trails, eTMF maintenance, data locking, and archival activities. • Mentor and coach junior associates while serving as a Subject Matter Expert across external data domains. • Contribute to SOPs, work instructions, guidance documents, training programs, and other External Data Services tools and templates. This role requires: • Bachelor's degree in Science, Health, Mathematics, Engineering, Computational Sciences, or a related field. • 7+ years of experience in External Clinical Data Acquisition or Clinical Data Management within biotechnology, pharmaceutical, or healthcare industries. • Experience handling multiple clinical data types including biomarker, eCOA, imaging, ECG, PK, genomics, and laboratory data. • Solid understanding of CDISC standards, database structures, and clinical data management procedures. • Knowledge of regulatory requirements, including 21 CFR Part 11 and ICH-GCP guidelines. • Sophisticated experience extracting and handling data in SAS, CSV, and XML formats. • Experience with EDC platforms such as Medidata Rave, Veeva, Oracle Inform, and external data reconciliation processes. • Strong project management,