Experienced Clinical Data Manager

Do you have significant Clinical Data Management experience? Can you envision using your expertise to make a positive impact on changing patients' lives? Then this role might be the one for you!

AstraZeneca is a global, innovation-driven BioPharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious disease.

Data Management (DM), part of Clinical Data and Insights (CDI), includes activities and tasks performed on clinical study data, including planning, data capture in CRF/eCRF and quality assurance up to Clean File/Database lock.

Join us and be part of a phenomenal place to work and an environment that energizes and empowers each of us to contribute to achieving our goal to develop and deliver life-changing medicines. We have roles at both Associate Director, Clinical Data Management and Senior Clinical Data Manager levels.



What you'll do

You will lead the Clinical Data Management (CDM) activities on assigned clinical studies as specialist on CDM processes, standards and technology. This is done in collaboration with internal and external partners on a local and global level, to ensure each study is run in accordance to the specifics of the model. Furthermore, you'll be responsible for maintaining business continuity for processes and standards, including integrity of the clinical database for the relevant studies.

Typical accountabilities:

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Study level CDM leadership, based on the relevant model and DM Vendor. This includes activities related to the study start up, conduct and closeout phases.
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Study status reporting, such as providing data to clinical teams for performing medical and clinical reviews, coordination of data review, lab data review, etc.
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Coordination of assigned projects regarding day to day operational aspects of assigned clinical studies - identifying risks and collaborate to mitigate the risk
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Drive the adherence to standards and processes as well as maintaining an awareness of the external and internal models, flagging for continuous improvement
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Input to activities associated with regulatory inspections and audits for assigned studies and to the selection and use of software systems, devices and vendors.
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Mentor junior colleagues



You can be based in one of our dynamic sites in Gothenburg - Sweden or Warsaw - Poland.



Essential for the role

You hold a university degree in life sciences or related field, which is complemented by significant Clinical Data Management experience. Furthermore, you have a proven knowledge of clinical databases, different systems and electronic data capture (EDC) as well as experience in query management process and reconciliation activities.

Your communications, leadership and collaboration skills are excellent, showcasing the ability to operate tactfully in a global setting across several cultures

You also possess:

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Proven understanding of Good Clinical Data Management Practices and relevant regulatory requirements
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Ability and flexibly to perform in a distributed team environment on simultaneous projects and proactively manage time to meet own goals
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Excellent analytical skills and high attention to detail



Desirable for the role

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Knowledge of clinical and pharmaceutical drug development process
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Ability to apply statistical techniques in the analysis of data from clinical studies
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Demonstrated understanding of the design, development and validation of clinical data systems
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Experience with effective external partner management
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Understanding of database structures, programming languages, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting
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Knowledge of SQL, 4GL, VBA or R software



Why AstraZeneca

Curious minds - we are driven by our desire to understand and reveal new insights. Ultimately, it's more than a job. We know that our work impacts people with serious conditions, many of whom have no other alternatives. That's what drives us - the potential to impact over one billion patients worldwide.



So, what's next!

If you are ready to bring new insights and fresh thinking to the table, we have one seat available, and we hope it's yours.

We look forward to receiving your application no later than January 16th, 2022



Where can I find out more

LinkedIn https://www.linkedin.com/company/1603/

Our R&D Story: https://www.youtube.com/watch?v=pmFx_jr2eFo