Senior Clinical Data Manager I
ROLE OVERVIEW
This Senior Clinical Data Manager I role at AstraZeneca places you at the heart of global clinical trial data delivery from the company's Bangalore hub. As an individual contributor, you will coordinate Clinical Data Management deliverables across start-up, conduct and closeout, ensuring data is captured, cleaned and submission-ready. The position sits within AstraZeneca's science-led, patient-focused R&D engine, where high-quality data directly fuels regulatory decisions and clinical insights. You will partner with clinical operations, biostatistics, safety, programming and external vendors, influencing study integrity and database lock readiness. For experienced CDM professionals, this is a compelling chance to deepen therapeutic and technical expertise, mentor junior colleagues, and work with scalable EDC and data standards in a hybrid, globally connected environment. It offers meaningful ownership without losing cross-functional collaboration.
ROLE DEFINITION & RESPONSIBILITIES
- •Coordinate CDM deliverables on assigned clinical studies across start-up, conduct, and closeout, ensuring alignment with study model, vendor and timelines.
- •Oversee day-to-day operational CDM activities, including documentation review/creation, user access testing, query management, data cleaning and third-party data reconciliation.
- •Act as CDM representative on Global Study Team for less complex studies, partnering with clinical operations, biostatistics, safety, programming and external data partners.
- •Identify, assess and mitigate data management risks; develop contingency plans and escalate issues that may impact database lock or submission milestones.
- •Protect database integrity from build through lock by driving adherence to AZ CDM standards, GCDMP, and data quality/consistency requirements.
- •Support regulatory inspection/audit readiness for assigned studies, maintaining Trial Master File compliance related to DM vendor oversight.
- •Provide input into selection/use of clinical systems, devices and vendors; recommend continuous improvements to CDM practices and technologies.
- •Mentor junior Clinical Data Management colleagues, share best practices, and handle ad hoc CDM requests from line management.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Graduate degree in life sciences, pharmacy, nursing or related discipline; advanced qualification in clinical research or data management is a plus.
- 8+ years of relevant clinical data management experience in biotech, pharmaceutical or CRO settings.
- End-to-end knowledge of CDM from study start-up through database lock and submission support.
- Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP) and applicable regulatory requirements.
- Hands-on experience with clinical databases, multiple CDM systems and electronic data capture (EDC) platforms.
- Proven ability to lead studies, manage query resolution and perform reconciliation activities with third-party data.
- Strong written and verbal communication skills, with ability to work flexibly across simultaneous global projects.
PREFERRED QUALIFICATIONS
- •SQL
- •4GL
- •VBA
- •R Programming
- •Clinical Data System Design & Validation
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
AstraZeneca is a global, science-led biopharmaceutical company focused on the discovery, development, and commercialisation of prescription medicines. The company operates in various therapeutic areas, including Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. AstraZeneca is committed to pushing the boundaries of science to deliver life-changing medicines and improve patient outcomes worldwide.
EXPECTED CAREER ROADMAP
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