Senior Clinical Data Manager (Late R&I)
- Experience Level
- Experienced (non-manager)
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 great 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.
Senior Clinical Data Manager helps with coordination the Clinical Data Management (CDM) results on assigned clinical studies and may be a specialist on CDM processes, standards and technology. Collaborates with vendors and links with a variety of departments on a local and global level to ensure each study is run in accordance to the specifics of the model. Maintains Business Continuity for processes and standards including integrity of the clinical database for the relevant studies.Typical accountabilities:
- Study level 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. (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, important metrics and project timelines.).
- Study status reporting (e.g. provide data to clinical teams for performing medical and clinical reviews, coordination of data review, lab data review, etc.), collaboration with vendors regarding upcoming results and milestone achievements (i.e., snapshots, interim, and migrations); oversight of the data and documentation quality.
- Assist with coordination assigned projects, regarding day to day operational aspects of assigned studies; responsible to identify risks and collaborate to mitigate the risk, responsible for compliance to Trial Master File requirements relating to vendors
- Understands therapeutic area, indication or program specific data capture standards and AZ standards, drive adherence to standards and processes for data quality and consistency, maintain an awareness of the external and internal models in order to flag for continuous improvement
- Provide input into activities associated with regulatory inspections/audits for assigned studies and to the selection and use of software systems, devices and vendors.
- Demonstrates willingness to seek ad hoc activities and mentoring junior colleagues
- University or college degree in the life sciences or related subject (pharmacy, nursing or equivalent)
- Knowledge of Clinical Data Management and proven track records in the Biotech/Pharma/CRO industry
- Shown current understanding of Good Clinical Data Management Practices and relevant regulatory requirements
- Experience of clinical databases, different systems and electronic data capture (EDC) - understanding and experience in query management process and reconciliation activities
- Ability to work flexibly in a distributed team environment on simultaneous projects and proactively manage time to meet own goals.
- Excellent written and verbal communication skills, interpersonal and analytical skills and high attention to detail
- Knowledge of clinical and pharmaceutical drug development process
- Ability to apply statistical techniques in the analysis of data from clinical studies or other relevant areas
- Demonstrated understanding of clinical data system design / development / validation and system interoperability
- Experience with effective external partner management
- 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
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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.