Associate Director - Clinical Study Data Management

Astrazeneca India Private Limited; Bengaluru; Hybrid; INR 2,500,000 - 4,500,000; Full time

Job summary

AstraZeneca India Private Limited is seeking an Associate Director Study Data Manager to lead end-to-end Clinical Data Management for assigned studies. Hybrid work model in Bengaluru with global collaboration and vendor oversight.

The role demands strong leadership, data governance, GCDMP knowledge, and experience overseeing EDC systems, data standards, and regulatory readiness across trials. You will mentor junior team members, coordinate with CROs, ensure quality deliverables, drive timelines

Qualifications

• Graduate or post graduate in the life sciences, pharmacy, or nursing.
• Solid knowledge of Clinical Data Management Practices and regulatory requirements.
• Strong project leadership and metrics reporting experience.
• Experience with external partners and data repositories.

Responsibilities

• Take end-to-end accountability for CDM deliverables on assigned studies.
• Oversee vendor performance and guide DM leads to meet timelines and quality.
• Provide expert oversight of day-to-day data operations and risk management.
• Contribute to data standards, governance, and regulatory readiness.
• Lead inspection readiness and regulatory input for trials.
• Support software systems selection, EDC configuration, and interoperability.
• Drive continuous improvement of DM operating models and processes.
• Mentor junior CDM staff to build capability across studies.

Skills

GCDMP

Project leadership

EDC systems

Vendor management

Data governance

Regulatory readiness

Cross-functional

Education

Life sciences degree

Pharmacy or nursing

Tools

EDC platforms

Job description

Associate Director Study Data Manager

Career Level - E

Location: Manyata Tech Park, Bangalore

Work Type: Hybrid

Accountabilities

• 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.

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. 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

Experience Level Mid Level