Associate Director Study Data Manager

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About the role

Job Title: Associate Director Study Data Manager • Career Level – E • Location: Manyata Tech Park, Bangalore • Work Type: Hybrid   Introduction to role: Are you ready to lead clinical data delivery that accelerates breakthrough medicines for patients with cancer? Step into a role where your judgment and leadership directly shape the speed, integrity, and readiness of pivotal trials. You will be the study-level data authority, aligning vendors, standards, and systems to deliver complete, inspection-ready datasets that inform go/no-go decisions and regulatory submissions. Working at the heart of a fast-moving portfolio, you will influence how data are captured, cleaned, and curated across multiple indications, ensuring quality that stands up to scrutiny. How will you apply your vendor leadership and data standards expertise to bring precision to every decision?   Accountabilities: • Study-Level Data Leadership: Take end-to-end accountability for Clinical Data Management deliverables on assigned studies, serving as the first line of contact and orchestrating plans, timelines, and quality outcomes. • Vendor Oversight and Performance: Act as primary point of contact for the DM vendor; guide and supervise the Lead Data Manager/DM Team Lead (CRO or in-house) to meet scope, timelines, and quality. Review delivery against KPIs, oversee billing accuracy, and recommend invoice payments. • Operational Excellence: Provide expert oversight of day-to-day data operations, ensuring proactive issue identification, robust mitigation with vendors, and timely escalation. Drive adherence to standards and processes to achieve consistent, high-quality data capture. • Standards and Governance: Contribute to corporate, therapeutic, and program-level data capture standards; champion adoption to improve consistency and downstream analysis readiness. • Inspection Readiness: Lead DM inspection preparation at the study level, provide input into regulatory inspections and audits, and ensure compliance with Trial Master File requirements. • Technology and Systems: Provide input to the selection and use of software systems, devices, and vendors as needed; bring practical insight to database build, EDC configuration, and interoperability considerations. • Risk and Change Leadership: Maintain awareness of internal and external trends; participate in change initiatives and continuous improvement activities to evolve DM operating models and ways of working. • Financial and Timeline Stewardship: Lead all aspects of vendor timelines and achievement deliverables; manage budget adherence and performance metrics to enable predictable, high-quality delivery. • People Development: Mentor junior Clinical Data Management colleagues, building capability and strengthening delivery across studies. Essential Skills/Experience: • Graduate or post graduate in the life sciences or pharmacy or nursing. • Solid knowledge of Clinical Data Management and experience in the Biotech/Pharma/CRO industry. • Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements. • Strong Project Management and Lead DM experience; Exhibits expertise in metrics analysis and reporting methodologies. • Demonstrated ability to work effectively with external partners. • Demonstrated experience with clinical data repositories, various clinical data management systems, and electronic data capture (EDC). • Demonstrate understanding along with background in query management process and reconciliation activities. • Good communication and interpersonal skills including effective problem solving. • Capable of working independently without close supervision. • Excellent written and verbal communication skills. • Capacity to contrib

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