Senior Clinical Data Manager I

Overview

• Global Career Level: D
• Role Type: Individual Contributor
• Location: Manyata Tech Park, Bangalore
• Work Type: Hybrid
• Experience: 8 to 12 years
• Coordinates Clinical Data Management deliverables on assigned projects depending on the relevant model and DM Vendor.
• Demonstrates leadership and operational knowledge in the planning and delivery of CDM deliverables at a study level.
• Oversees the day-to-day operational aspects of CDM for assigned studies. This may include but is not limited to activities related to the study start up, conduct and closeout phases (i.e., documentation review and/or creation, User Access Testing, query management, data cleaning and reviews, third party data reconciliation in accordance with the project study model, KPIs (Key Performance Indicators) and project timelines).
• Responsible for risks identification and mitigation.
• Provide input into CDM related activities associated with regulatory inspections/audits for assigned studies.
• May provide input to the selection and use of software systems, devices, and vendors.
• Responsible for compliance with Trial Master File requirements relating to DM Vendor.
• Drive adherence to AZ CDM standards and processes for data quality and consistency of data capturing for assigned studies.
• Maintain awareness of internal and external operating models to identify and recommend continuous improvements to CDM practices.
• Demonstrates willingness to take on ad hoc activities consistent with current or experience in support of CDM.
• Mentoring junior Clinical Data management colleagues
• Performs CDM related ad-hoc requests from Line Manager
• Graduate in the life sciences or related subject like pharmacy or nursing.
• 8+ years of relevant background in the Clinical Data Management
• 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).
• Demonstrated 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 environment.
• Excellent organizational and analytical skills and high attention to detail.
• Demonstrated knowledge of the clinical and pharmaceutical drug development process.
• 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.

Job Title: Senior Clinical Data Manager I

About AstraZeneca:

AstraZeneca is a global, science-led, patient-focused pharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines targeting some of the planet’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we 're dedicated to being a Great Place to Work.

Introduction to role:

Coordinates the Clinical Data Management (CDM) deliverables on assigned clinical studies and acts as an expert on CDM processes, standards and technology. Ensures the data is properly captured, cleaned, and ready to support regulatory submissions and clinical insights. Protects database integrity from build through lock. Operates at the center of cross-functional study delivery being a member of the Global Study Team (GST) for less complex studies - partnering with clinical operations, biostatistics, safety, programming, and external data partners. Collaborates with DM vendors and liaise with a variety of departments on a local and/or global level to ensure each study is run in accordance to the specifics of the model. May work under direction of a Project Data Manager.

Accountabilities:

Essential Skills/Experience:

Desirable Skills/Experience:

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.

Why AstraZeneca:

Join an organization passionate about science, data, and technology to drive meaningful breakthroughs for patients. You will work shoulder to shoulder with clinicians, biostatisticians, operations specialists, and data scientists—often around the same table—turning ambitious questions into concrete study plan