Senior Clinical Data Manager I

Roles & Responsibilities

• Lead end-to-end study-level Clinical Data Management activities from start-up to database lock and closeout
• Prepare and execute Data Management Plans, data cleaning strategies, and query workflows
• Perform ongoing data review including clinical, lab, and third-party data reconciliation
• Manage data management vendors, snapshots, interim analyses, and data migrations
• Track KPIs, manage timelines, and identify operational risks
• Ensure inspection readiness, audit support, and TMF compliance
• Apply CDISC (SDTM, ADaM) and AstraZeneca data standards
• Mentor junior CDM team members and support process improvements

Qualification

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Clinical Research, Biotechnology, or related field

Experience

• Study-level Clinical Data Management experience in pharma, biotech, or CRO settings
• Experience with global clinical trials, EDC systems, and third-party data
• Exposure to database lock, audits, and regulatory inspections

Skills

• Strong EDC, query management, and data quality oversight expertise
• Vendor management and operational metrics tracking
• Knowledge of CDISC standards (SDTM, ADaM)
• Strong cross-functional communication skills
• Experience with complex trials or interim analyses is a plus

About the Organisation

AstraZeneca is a global biopharmaceutical company focused on innovative, science-led medicines. The Bangalore site supports global clinical development, offering opportunities to work on high-impact trials and grow within a world-class research organization.