Associate Director Study Data Manager

AstraZeneca; Bengaluru; Hybrid; INR 4,000,000 - 6,000,000; Full time

Job summary

AstraZeneca is seeking an Associate Director Study Data Manager in Bengaluru to lead clinical data management for multi-indication trials. The role requires strong vendor oversight, data standardization, and peak readiness for inspections, with accountability for timelines, quality, and regulatory alignment.

You will mentor junior data management staff, shape data capture strategies, and drive continuous improvements across a fast-moving portfolio, blending internal and external collaborations.

Qualifications

• Graduate or post graduate in the life sciences or pharmacy or nursing.
• Solid knowledge of Clinical Data Management and experience in Biotech/Pharma/CRO industry.
• Demonstrated understanding of GCDMP and regulatory requirements.
• Strong Project Management and Lead DM experience with metrics analysis and reporting.

Responsibilities

• Study-Level Data Leadership: end-to-end accountability for CDM deliverables on assigned studies.
• Vendor Oversight: primary contact for DM vendor; guide and supervise teams to meet scope, timelines, and quality.
• Operational Excellence: oversee day-to-day data operations; ensure proactive issue identification and mitigation.
• Standards and Governance: contribute to data capture standards; champion adoption for consistency.
• Inspection Readiness: lead DM inspection prep and support regulatory inspections and audits.
• Risk and Change Leadership: participate in change initiatives and continuous improvement.

Skills

Clinical Data Management

Project Management

Vendor Oversight

GCDMP

Education

Bachelor's/Master's in Life Sciences/Pharmacy/Nursing

Tools

EDC systems

CDISC standards

Clinical data repositories

Job description

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 contribute effectively in a distributed team environment.
• Excellent organizational and analytical skills, sound decision making skills, and high attention to detail.

Desirable Skills/Experience:

• Proven grasp of the clinical and pharmaceutical drug development process.
• Brand-new understanding of database structures, programming languages, data standards (CDISC) and practices as they apply to CRF build, database development, data handling and reporting.
• Proven knowledge of system build / development / validation related to clinical information and system interoperability.
• Demonstrates professionalism, diplomacy, mutual respect and the ability to manage/value diversity and cultural differences and promote productivity through encouragement.
• Experience within Sponsor organization and Regulatory inspections

Why AstraZeneca:

Here, science, data, and technology converge to deliver the next wave of breakthroughs for patients who need them most. You will work alongside biologists, clinicians, statisticians, and data scientists. These unexpected groups come together to encourage bold thinking. You will also be trusted to explore new approaches and supported in continuous learning. With a dynamic pipeline across multiple disease areas and access to modern platforms, you will shape how high-quality data speeds confident decisions and clinical success. We value rigor and curiosity as much as kindness and collaboration, and we celebrate learning - whether it comes from success or from taking smart risks - so your contributions can lead to real-world impact and, when the science deserves it, publication.

Find out more by following AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Date Posted

12-Oct-2026

Closing Date

18-Oct-2026

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.