Clinical Data Manager

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/Additional Preferences

• Experience across study and/or program-level delivery.
• Vendor management and external partner oversight experience.
• Inspection readiness and regulatory submission exposure.
• Experience handling complex data sources (e.g., eCOA, biomarker, imaging).
• Strong understanding of end-to-end clinical data flow, from patient data capture through analysis ready dataset delivery.
• Engagement with industry practices (e.g., SCDM standards).
• Ability to work across compounds and therapeutic areas, including medical coding, adjudication, and decommissioning activities.
• Willingness to travel based on business needs.
• People management is not a core expectation. Supervisory responsibilities may occur based on business needs but are not explicitly differentiated across levels.
• Job is in Bengaluru, India.

At Lilly, caring is not only what we do for patients. It is how we work. We believe the people who dedicate themselves to making medicines better deserve an environment that makes their lives better too, one where they are supported, respected, and given the space to do their best work. This is not just a policy. It is who we are.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

#WeAreLilly