Clinical Data Manager
- Experience Level
- Entry level
At AstraZeneca, we are guided in our work by a strong set of values, and we're resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we're on a mission to turn ideas into life-changing medicines that transform lives. We need phenomenal people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you're swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
Clinical Data Coordinator supports the Clinical Data Management (CDM) in delivery of high-quality data for assigned clinical studies or indications that are led internally or externally. Collaborates with DM vendors and link with different teams on a local and global level to ensure each project is run in accordance to the specifics of the model. Provides solutions to a variety of issues relating to CDM administration of moderate scope and complexity whilst adhering to methodology standards.Typical accountabilities:
- Study level CDM administrative support based on the relevant model and DM Vendor. This may include but is not limited to 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, critical metrics and timelines.)
- Day to day responsibilities may include but are not limited to: a) study status reporting (e.g. provide data to clinical teams for performing medical and clinical reviews, coordination of data review, lab data review, etc.); b) collaboration with Data Management Vendor regarding upcoming results and achievements (i.e., snapshots, interim, and migrations); c) oversight of the data and documentation quality.
- Reporting in CDM specified systems results and achievements, risks and mitigations and data transfer agreements, and other study administrative needs.
- Responsible for the tracking of findings and outcomes (e.g. RCA and CAPA) to meet Quality Compliance requirements.
- Oversight of Trial Master File compliance for audit readiness. May include activities related to study Expected Data Lists and quality compliance checks.
- Performs User Acceptance Testing of internal and external electronic Data Capture systems.
- Provides support to the resolution of issues and inputting ideas to help resolve issues and contribute to continuous improvement.
- Performs any CDM related ad-hoc requests.
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.