AstraZeneca
ClinicalDataManagerII
Neural analysis suggests this role is
optimal for Mid candidates.
“Clinical Data Manager II at AstraZeneca. Skills: Clinical Data Management. Support Clinical Data Management (CDM) delivery. Collaborate with DM vendors”
Industry & Context.
Problem resolution
What They're Looking For.
Must Have
University or college degree in life sciences or related subject, pharmacy, nursing or equivalent relevant degree, Clinical Data Management Experience, Fluent English (oral and written), Attention to detail, Good verbal and written skills, Ability to work flexibly on simultaneous projects, Proactively manage time to meet own deadlines, Interpersonal skills, Proven ability to communicate effectively in a global environment
Nice to Have
Basic understanding of clinical trials methodology, GCP understanding, Medical terminology understanding, Understanding of database structures, Understanding of programming languages, Understanding of data standards (CDISC), Understanding of practices as they apply to CRF design, Understanding of database development, Understanding of data handling, Understanding of reporting, Knowledge of SQL, Knowledge of 4GL, Knowledge of VBA, Knowledge of R software
What You'll Do.
Support Clinical Data Management (CDM) delivery
Collaborate with DM vendors
Liaise with a variety of departments
Provide solutions to issues related to CDM administration
Perform study level CDM administrative support
Perform User Access Testing
Perform data cleaning
Perform third party data reconciliation
Provide data to clinical teams
Coordinate instream data review
Coordinate lab data review
Collaborate with Data Management Vendor
Oversee documentation quality
Report in CDM specified systems
Meet Quality Compliance requirements
Oversee Trial Master File compliance
Perform User Acceptance Test of electronic Data Capture
Support resolution of issues
Input ideas to help resolve issues
Contribute to continuous improvement
Perform CDM related ad-hoc requests
Mentor junior clinical data management colleagues
Deputise Data Management Delivery Lead
How You'll Work.
Team & Collaboration
Global environment; Clinical study team members; Data Management Vendor
Communication Scope
Verbal skills; Written skills; Communicate effectively
Full Job Description
**_Position: Clinical Data Manager II_** ** _Hybrid work - Location: Warsaw_** **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 really deliver on what science can do and to always put patients first. Working at AstraZeneca we believe in the potential of our people and our commitment to develop our people beyond what was thought possible. **ABOUT THE ROLE** Support Clinical Data Management (CDM) delivery of high-quality data for assigned medium complex clinical studies or indications that are managed by various Data Management Sourcing Models. Collaborates with DM vendors and liaise with a variety of departments on a local and/or global level to ensure each project is run in accordance to the specifics of the model. Provides solutions to a variety of issues related to CDM administration of moderate scope and complexity whilst adhering to methodology standards. May work under direction from an experienced Senior Clinical Data Manager or Data Management Delivery Lead ## ## **Responsibilities include:** • Study level CDM 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, KPIs (Key Performance Indicators) and timelines.) • Day to day responsibilities may include but are not limited to • Study status reporting to the relevant clinical study team members, (e.g., provide data to clinical teams for performing medical and clinical reviews, coordination of instream data review, lab data review, etc.) • Collaboration with Data Ma
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