AstraZeneca

ClinicalDataManagerII

$185–275k ~AI est. Warsaw, Poland FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid candidates.

The Brief

“Clinical Data Manager II at AstraZeneca. Skills: Clinical Data Management. Support Clinical Data Management (CDM) delivery. Collaborate with DM vendors”

Industry & Context.

Problems you'll solve

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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