Senior Clinical Data Manager

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 **Senior Clinical Data Manager **to join our team. You'll assist with coordination the Clinical Data Management (CDM) deliverables on assigned clinical studies and may be an expert on CDM processes, standards and technology. May be member of the Global Study Team (GST) for less complex studies. Collaborates with DM vendors and liaise with a variety of departments on a local and/or global level to ensure each study is run in accordance to the specifics of the model. Maintains Business Continuity for CDM processes and standards including integrity of the clinical database for the relevant studies. May work under direction of an experienced 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 project 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.
- Assist with coordination in the Clinical Data management deliverables on assigned projects depending on the relevant model and DM Vendor.
- Oversight of the day to day operational aspects of CDM for assigned studies; Responsible to identify risks and collaborate with the Principle Clinical Study Data Manager to mitigate the risk.
- Understands therapeutic area, indication or program specific data capture standards and AZ standards.
- Provide input into CDM related activities associated with regulatory inspections/audits for assigned studies.
- May provide input to the selection and use of software systems, devices and vendors.
- Responsible for compliance to Trial Master File requirements relating to DM Vendor
- Drive adherence to AZ CDM standards and processes for data quality and consistency of data capturing for assigned studies
- Maintain an awareness of the external and internal models in order to flag for continuous improvement related to CDM operating models.
- Demonstrates willingness to take on ad hoc activities consistent with current or experience in support of CDM.
- Mentoring junior Clinical Data management colleagues
- Performs any CDM related ad-hoc requests from Line Manager or superior

**Essential requirements**
- Knowledge of Clinical Data Management and experience in the Biotech/Pharma/CRO industry
- Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements
- Demonstrated experience of clinical databases, different clinical data management systems and electronic data capture (EDC)
- Demonstrate understanding and experience in query management process and reconciliation activities
- Ability to work flexibly on simultaneous projects and proactively manage time to meet own deadlines.
- Excellent written and verbal communication skills
- Ability to work in a global team environment
- Excellent organizational and analytical skills and high attention to detail

**Desirable requirements**
- Demonstrated knowledge of clinical and pharmaceutical drug development process
- Demonstrated understanding of clinical data system design / development / validation and system interoperability.
- Demonstrated ability to work effectively with external partners
- Knowledge of SQL, 4GL, VBA or R software

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