Clinical Data Manager II

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 Management Vendor regarding upcoming deliverables and milestone achievements (i.e., snapshots, interim, and migrations).

• Oversight of the data quality, documentation quality, and types of these deliverables and milestones.

• Responsible for the reporting in CDM specified systems and types of deliverables, milestone achievements, risks and mitigations and data transfer agreements, and other study administrative needs.

• Responsible to meet Quality Compliance requirements.

• Oversight of Trial Master File compliance for audit readiness.

• Performs User Acceptance Test of internal and external electronic Data Capture systems as required.

• Provides support to the resolution of issues related to Clinical Data Management deliverables and inputting ideas to help resolve issues and contribute to continuous improvement.

• Performs any CDM related ad-hoc requests from Line Manager or superior.

• Mentor junior clinical data management colleagues.

• May deputise Data Management Delivery Lead

Education, Qualifications, Skills and Experience

Essential

• University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree.

• Clinical Data Management Experience.

• Languages: Fluent English (oral and written)

• Attention to detail to ensure quality

• Good verbal and written skills

• Ability to work flexibly on simultaneous projects and proactively manage time to meet own deadlines.

• Strong interpersonal skills and proven ability to communicate effectively in a global environment.

Desirable

• Basic understanding of clinical trials methodology, GCP and medical terminology

• 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

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.