Senior Clinical Data Manager II
Location: Warsaw, Poland (Hybrid Working Model)
About AstraZeneca
At AstraZeneca, every one of our employees makes a difference to patient lives every day. You may not feel you're at the frontline of research, but your role in changing patients' lives is critical.
Our mission is ambitious, and it takes the skills of a collaborative team to truly deliver on what science can do and to always put patients first. At AstraZeneca, we believe in the potential of our people and are committed to developing them beyond what was thought possible.
The Role
The successful candidate will be responsible for the coordination of Clinical Data Management (CDM) deliverables on assigned clinical studies and may be an expert on CDM processes, standards, and technology.
The role may involve acting as a Core member of the Global Study Team (GST) and leading studies with less complexity. You will collaborate with Data Management vendors and liaise with a variety of departments at both local and global levels to ensure each study is run in accordance with the specifics of the model.
You will maintain Business Continuity for CDM processes and standards, including the integrity of the clinical database for relevant studies, and may work under the direction of a Project Data Manager.
Key Responsibilities
- Coordinate Clinical Data Management deliverables on assigned studies, depending on the relevant model and DM Vendor. Take accountability and serve as the first line of contact at the study level.
- Demonstrate leadership and operational knowledge in the planning and delivery of CDM deliverables at a study level, potentially under the mentorship of a Project Data Manager.
- Communicate and collaborate effectively with all study team members.
- Act as the primary point of contact for the DM Vendor and provide guidance and supervision to the Lead Data Manager/DM Team Lead working on the study (CRO or in-house).
- Provide oversight of day-to-day operational aspects of CDM for assigned studies.
- Identify risks and collaborate with the DM Vendor to mitigate them. Escalate issues and risks when necessary.
- Understand corporate, therapeutic/indication-specific, or programme-specific data capture AstraZeneca standards.
- Provide input into CDM-related activities associated with regulatory inspections and audits for assigned studies.
- Support Senior Leaders in overseeing CDM Vendor performance, depending on the relevant model.
- Review, assess, and manage DM Vendor delivery against KPIs, budget, and overall performance.
- Oversee vendor timelines and milestone deliverables for assigned studies.
- Ensure DM Vendor billing is accurate and provide recommendations for payment of invoices.
- Drive adherence to AstraZeneca CDM standards and processes for data quality and consistency of data capture for assigned studies.
- Demonstrate willingness to take on ad hoc activities consistent with current CDM work experience.
- Ensure relevant training is completed prior to performing tasks.
- Mentor junior Clinical Data Management colleagues.
- Perform CDM-related ad hoc requests from the Line Manager.
Education, Qualifications, Skills and Experience
Essential
- University or college degree in Life Sciences or a related subject, Pharmacy, Nursing, or an equivalent relevant degree.
- Knowledge of Clinical Data Management and experience within the Biotech, Pharmaceutical, or CRO industry.
- Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements.
- Demonstrated experience with clinical databases, different clinical data management systems, and Electronic Data Capture (EDC).
- Demonstrated understanding and experience of query management processes and reconciliation activities.
- Ability to work flexibly across simultaneous projects and proactively manage time to meet deadlines.
- Excellent written and verbal communication skills.
- Ability to work effectively in a global team environment.
- Excellent organisational and analytical skills, with a high level of attention to detail.
Desirable
- Demonstrated knowledge of the clinical and pharmaceutical drug development process.
- 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 or SAS software.
- Experience leading clinical studies as a Data Management Lead.
Date Posted
01-cze-2026Closing Date
13-cze-2026AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
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