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
Job Description
Accountabilities
As a Senior Clinical Data Manager II, you will coordinate the Clinical Data Management deliverables on assigned studies, serve as the first line of contact at the study level, and demonstrate leadership in planning and delivering CDM deliverables. You will be responsible for overseeing day-to-day operational aspects of CDM for assigned studies, identifying risks, and collaborating with the DM Vendor to mitigate these risks. You will also provide input into CDM related activities associated with regulatory inspections/audits for assigned studies and ensure compliance to Trial Master File requirements relating to DM Vendor.
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
- Experience with clinical databases, different clinical data management systems and electronic data capture (EDC)
- 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
- Knowledge of clinical and pharmaceutical drug development process
- Understanding of clinical data system design / development / validation and system interoperability
- 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 or SAS software
- Experience leading clinical studies as Data Management Lead
Additional Information
Qualification : University or college degree in life sciences or related subject, pharmacy
Location : Bangalore
Industry Type : Pharma / Healthcare / Clinical research
End Date : 12-Oct-2024
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