Clinical Data Manager

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. Clinical Data Manager About Lilly At Lilly, everything we do starts with patients. We unite caring with discovery to make life better for people around the world. Headquartered in Indianapolis, Indiana, our global team of over 50,000 employees work with urgency and purpose to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. We bring our best to this work because people depend on it. If you're driven by purpose and determined to make a meaningful difference for patients, we invite you to bring your skill and your commitment to Lilly. About Lilly Research Labs, Bengaluru At Lilly in Bengaluru, the research function works directly alongside Lilly's global teams to advance the science behind tomorrow's medicines. Whether through product research and development, computational modelling, data-driven experimentation, or the intelligence that shapes Lilly's external innovation strategy, the work here contributes to the pipeline that will determine which life-changing medicines reach patients across the globe. Job Description Purpose The Clinical Data Management role within Clinical Data Sciences is responsible for delivering high-quality clinical trial data across the end-to-end data lifecycle from study setup through conduct, closure, and regulatory submission. This role applies expertise in data integrity, blinding concepts, data collection and design, data flow management, data quality, data validation, data review, medical coding, data technology, adjudication coordination, archiving, and decommissioning and dataset delivery to ensure accurate, consistent, and regulatory-compliant clinical data. The role collaborates with cross-functional stakeholders and external partners to enable timely and high-quality study execution across trials and programs. The scope of accountability increases based on complexity, ownership, and enterprise influence, with role progression driven through competencies. Primary Responsibilities This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any role/position can change over time and can include additional responsibilities not specifically described in the job description. Consult with your supervisor regarding your actual job responsibilities and any related duties that might be required for the role/position. Project Management - Execute and/or lead clinical data management activities across study lifecycle (setup, conduct, closure). - Ensure completeness, accuracy, and integrity of clinical data to support regulatory reporting and submissions. - Manage data acquisition, database design, validation, review, medical coding, and dataset delivery aligned to protocol objectives. - Ensure seamless integration of data from multiple sources (e.g., lab, eCOA, imaging, biomarker). - Drive study milestones including clean file readiness and database lock timelines. - Identify, track, and resolve data quality issues in collaboration with internal and external stakeholders. - Contribute to or lead clinical data management strategy at study and/or program level. - Provide oversight of vendors, including performance monitoring, issue resolution, and continuous improvement. - Monitor progress, quality, and risks; escalate as appropriate. - Support inspection readiness and regulatory activities (e.g., audits, submissions, responses). - Ensure compliance with data standards, SOPs, and global regulations (e.g., ICH-GCP, FDA, MHRA). - Partner with Clinical Operations, Biostatistics, Medical, Programming, and Data Science teams. - Align data strategy with protocol requirements and analysis needs. - Negotiate deliverables, timelines, and scope balancing cost, quality, and efficiency. - Identify and implement process improvements to enhance data quality and operational efficiency. - Contribute to development and adoption of standards, SOPs, and best practices. - Support knowledge sharing and capability building across the Clinical Data Sciences organization. Enterprise Leadership - Proactively identify and implement process improvements to reduce cycle time and enhance operational efficiency. - Represent Data and Analytics processes and best practices in cross-functional initiatives. - Actively contributes to shared learning, and continuous capability development across the Data and Analytics organization. - Provide guidance, mentorship, or oversight as needed. - Support prioritization, resource planning, and operational decision making. - Influence stakeholders through expertise, insights, and strategic thinking. Minimum Qualification Requirements - Master's/Professional degree in Pharmacy, Health and Life Sciences or related field. - Relevant experience in clinical drug development, with 2+ years experience in Clinical Data Management. - Strong understanding of clinical trial methodology, GCP, and medical terminology. - Knowledge of clinical data lifecycle processes and data standards. - Familiarity with clinical data systems and technologies. - Demonstrated ability to collaborate, influence, and deliver results. - Strong communication, analytical, and project management skills. Other Information/Addit