Astrazeneca
Pharmaceutical
SeniorClinicalDataManagerII
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Clinical Data Manager II at Astrazeneca. Skills: Clinical Data Management. Coordinate Clinical Data Management deliverables. Serve as the first line of contact at”
Industry & Context.
Analytical skills
What They're Looking For.
Must Have
University or college degree in Life Sciences or a related subject, Pharmacy, or Nursing, Knowledge of Clinical Data Management, Experience within the Biotech, Pharmaceutical, or CRO industry, Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP), Demonstrated experience with clinical databases, Demonstrated experience with Electronic Data Capture (EDC), Demonstrated understanding and experience of query management processes, Demonstrated experience of reconciliation activities, Ability to work flexibly across simultaneous projects, Proactively manage time to meet deadlines, Ability to work effectively in a global team environment, Excellent organisational and analytical skills, High level of attention to detail
Nice to Have
Demonstrated knowledge of the clinical and pharmaceutical drug development process, Demonstrated understanding of clinical data system design, development, validation, Demonstrated understanding of system interoperability, Demonstrated ability to work effectively with external partners, Understanding of database structures, Understanding of programming languages, Understanding of data standards (CDISC), Knowledge of SQL or SAS software, Experience leading clinical studies as a Data Management Lead
What You'll Do.
Coordinate Clinical Data Management deliverables
Serve as the first line of contact at
Demonstrate leadership and operational knowledge in planning and
Communicate and collaborate effectively with all study team
Act as the primary point of contact for
Provide guidance and supervision to the Lead Data
Provide oversight of day-to-day operational aspects of CDM
Identify risks and collaborate with the DM Vendor
Escalate issues and risks when necessary
therapeutic/indication-specific
or programme-specific data capture AstraZeneca
Provide input into CDM-related activities associated with regulatory
Support Senior Leaders in overseeing CDM Vendor performance
and manage DM Vendor delivery against
Oversee vendor timelines and milestone deliverables
Ensure DM Vendor billing is accurate
Provide recommendations for payment of invoices
Drive adherence to AstraZeneca CDM standards and processes
Ensure relevant training is completed prior to performing
Mentor junior Clinical Data Management colleagues
Perform CDM-related ad hoc requests from the Line
How You'll Work.
Team & Collaboration
Global Study Team; Global team environment; External partners
Communication Scope
Written communication; Verbal communication
Full Job Description
**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 assign
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