Require Senior Clinical Data Manager at AstraZeneca

AstraZeneca contributes meaningfully to the UK beyond the provision of our medicines and the benefits they provide to the health of the nation. We commissioned a report in 2009 to measure our significant investment to the UK economy, which includes investment in jobs and wealth creation. Oxera, an independent economic consultancy provided the analysis for this report.

Post : Senior Clinical Data Manager I

Job Description
Assist with coordination the Clinical Data Management (CDM) deliverables on assigned clinical studies and may be an expert on CDM processes, standards, and technology. May be a member of the Global Study Team (GST) for less complex studies. 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 with the specifics of the model. Maintains Business Continuity for CDM processes and standards, including the integrity of the clinical database for the relevant studies. May work under the direction of an experienced Principal Clinical Data Manager.

Accountabilities : In this role, you will provide study-level CDM administrative support based on the relevant model and DM Vendor. This may include but is not limited to activities related to the study start-up, conduct, and closeout phases. You will also have day-to-day responsibilities such as study status reporting to the relevant clinical study team members, collaboration with Data Management Vendor regarding upcoming deliverables and milestone achievements, and oversight of the data quality, documentation quality, and types of these deliverables and milestones.

Candidate Profile
- University or college degree in life sciences or related subject, pharmacy, nursing, or equivalent relevant degree
- 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 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.

- Demonstrated knowledge of clinical and pharmaceutical drug development process
- State of the art understanding 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
- Understanding of database structures, programming languages, data standards (CDISC), and practices as they apply to CRF design, database development, data handling, and reporting
- Knowledge of SQL, 4GL, VBA, or R software

Additional Information
Qualification : University or college degree in life sciences or related subject, pharmacy, nursing
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th November, 2023