Principal Clinical Project 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.

Development Operations is here to deliver science through a wide range of specialist expertise, operational excellence and data driven innovation. These enable us to drive extensive clinical trial programs from design to regulatory submission and approval. Providing the key connection between science and commercialisation, we deliver trials and submissions to the highest standards of quality, efficiency and ethics to thousands of patients globally.

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.

What you'll do

As Principal Clinical Project Data Manager, you'll have the oversight responsibility of the Clinical Data Management (CDM) delivery of high-quality data externally or internally run clinical trials. You will partner with global external vendors as well as internal project teams, providing CDM leadership for your assigned projects, indications and studies.

Collaboration is key in this role, and we expect you to nurture a well-functioning partnership with external as well as internal collaborators. You are not afraid of holding others accountable for their responsibilities, and you communicate in a clear and respectful way.

Additionally, you will be the assigned specialist on CDM projects and technology, ensuring up-to-date awareness of trends and changes are applied in external CDM approaches. You will also be the subject matter expert in process development and improvement. Furthermore, you will mentor, coach and train junior colleagues by applying encouraging leadership.

This role will be responsible for:

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Management and oversight of vendor contracts, resourcing and budget and vendor performance for assigned projects and studies
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Identify and assist in successful application of consistent CDM processes and documentation across assigned projects, (i.e. ensuring consistency across data quality plans)
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Providing oversight and expertise of external service providers or in-house teams to deliver quality data with compliance to study model procedures and standards; give mentorship on AZ standards, processes, systems and expectations to external partners, internal partners and third-party vendors
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Proactive risk management and issue resolution and partner concern connected to Clinical Data Management improvement or technology
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Develop an understanding of recognized industry standards and impact to programming team to ensure consistency of program level standards such as CDASH and SDTM
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Act as the specialist in TA specific data capture and standards
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Provide input into the CDM related activities associated with regulatory inspections and audits



You can be based in Gothenburg - Sweden, Cambridge - UK, Gaithersburg - US 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 from Pharma or CRO. Your communications and collaboration skills are excellent, showcasing the ability to operate tactfully in a global setting across several cultures.

Furthermore, you have an extensive knowledge of database structures and of capturing and storing clinical information as they apply to CRF design, database development, data handling and reporting.

You also possess:

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Proven track record to successfully manage simultaneous trials and meet deadlines
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Excellent understanding of clinical trials methodology, GCP, GDMP and medical terminology
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Extensive knowledge of clinical standards, e.g. SDTM or CDASH
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High attention to detail and a strong analytical mind-set
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The ability to drive innovations



Desirable for the role

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Experience as a lead of early phase trials
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Minimum of 7 years Data Management experience
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Specific knowledge in the TA area of Respiratory and Immunology
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Experience of managing teams.



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 April 27th, 2021.