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About the role
- Senior Clinical Data Manager providing project support and oversight for clinical data management at AstraZeneca. Ensuring data quality and regulatory compliance in clinical studies.
Responsibilities
- Project level CDM administrative support for project(s) based on the relevant model and DM Vendor.
- Study status reporting to the relevant clinical study team members.
- Collaboration with Data Management Vendor regarding upcoming deliverables and milestone achievements.
- Oversight of the data quality, documentation quality, and types of these deliverables and milestones.
- Assist with coordination in the Clinical Data management deliverables on assigned projects.
- Responsible for compliance to 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 project(s).
- Maintain an awareness of the external and internal models related to CDM operating models.
- Mentoring junior Clinical Data management colleagues.
Requirements
- University or college degree in the 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 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.
Benefits
- AstraZeneca is an equal opportunity employer.
- Provides equal employment opportunities without discrimination.
- Commitment to diversity and inclusion in the workplace.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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