Senior Clinical Data Manager I Bengaluru, Karnataka, India

Location Bengaluru, Karnataka, India

Job ID R-233066

Date posted 10/08/2025

Job Title: Senior Clinical Data Manager I

Career Level: D

Introduction to role:

Are you ready to dive into the world of Clinical Data Management and make a significant impact on global health? As a Senior Clinical Data Manager I, you'll coordinate CDM deliverables for assigned clinical studies, ensuring they align with our high standards and innovative processes. You'll collaborate with diverse teams and vendors, maintaining the integrity of clinical databases and supporting the Global Study Team for less complex studies. This role offers the chance to be at the forefront of data management in the biotech and pharmaceutical industry, working under the guidance of experienced Study Data Managers.

Accountabilities:

In this dynamic role, you'll provide operational support at the study level, managing activities from start-up to closeout phases. Your leadership will be crucial in planning and delivering CDM deliverables, reporting study status, and collaborating with vendors on milestones. You'll oversee data quality, documentation, and compliance with Trial Master File requirements. With a keen understanding of therapeutic areas and AZ standards, you'll identify risks and work with Study Data Managers to mitigate them. Your input will be valuable in regulatory inspections and audits, as well as in software system selection. You'll drive adherence to CDM standards, flagging opportunities for continuous improvement, and mentor junior colleagues while handling ad-hoc requests.

Essential Skills/Experience:

• This candidate should have Data Management experience, with an expertise in External data vendor data types and Process.

• The role demands the associate to lead Third Party Activities of 2-3 studies and provide Subject Matter Expertise. Activities include, but are not limited to, creating Transfer Agreements, specifications and other critical TPV related documents, highlight timely risks and provide mitigations. It is mandatory for the role to ensure that high quality and meet timelines as expected for the projects.

• Support audit and inspections.

• Have an understanding of Data Standards and cleaning checks.

• Successful performance in this role requires leadership, Partner management, managing priorities, and strong communication skills.

• University or college degree in life sciences or related subject, pharmacy, nursing or equivalent relevant degree.
• End-to-end 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.
• Demonstrated experience of clinical databases, different clinical data management systems and electronic data capture (EDC).
• Demonstrate understanding and experience in leading studies, query management process and reconciliation activities.
• Ability to work flexibly on simultaneous projects and proactively manage time to meet own deadlines.
• Excellent written and verbal communication skills.
• Ability to work in a global team environment.
• Excellent organizational and analytical skills and high attention to detail.

Desirable Skills/Experience:

• Demonstrated knowledge of clinical and pharmaceutical drug development process.
• Knowledge of database structures, programming languages, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting.
• Demonstrated understanding of clinical data system design / development / validation and system interoperability.
• Demonstrated ability to work effectively with external partners.
• Knowledge of SQL, 4GL, VBA or R Programming.

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.

At AstraZeneca, we are driven by our passion for science and innovation. Our commitment to exploring new frontiers allows us to tackle some of the world's most complex diseases. By fusing data and technology with scientific breakthroughs, we are shaping the future of healthcare. Our inclusive environment encourages collaboration across academia, biotechs, and industry, creating swift impacts on disease treatment. With a focus on lifelong learning and growth, AstraZeneca offers a place where you can build a meaningful career while making a difference in patients' lives worldwide.

Ready to make your mark in the world of Clinical Data Management? Apply now to join our team!

Date Posted

Closing Date

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.