Clinical Data Manager Ii

hace 5 meses

Barcelona, España AstraZeneca A tiempo completo

**Location**:Barcelona

**About AstraZeneca**

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development, and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for their ideas and creativity.

**About the role**

We are seeking a knowledgeable and passionate** Clinical Data Manager II** to join our team. You'll support of the Clinical Data Management (CDM) delivery of high-quality data for assigned clinical studies or indications that are managed internally or externally by a DM (Data Management) vendor. You'll collaborate 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. You'll provide solutions to a variety of issues relating 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 Principal Clinical Data Manager.

**Typical Accountabilities**
- 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 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 for the tracking of findings and outcomes (e.g. RCA and CAPA) to meet Quality Compliance requirements.
- Oversight of Trial Master File compliance for audit readiness. May include activities related to study Expected Data Lists and quality compliance checks.
- Performs User Acceptance Testing 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

**Essential requirements**
- 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 requirements**
- Basic understanding of clinical trials methodology, GCP and medical terminology
- Knowledge of SQL, 4GL, VBA or R software

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