Data Quality Manager
AstraZeneca / Kemiingenjörsjobb / Göteborg
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hela Sverige AstraZeneca's Early Clinical Biometrics group are looking for talented Data Quality Manager to join our Clinical Trial Data Science group at AstraZenecas R&D site in Gothenburg, Sweden or Cambridge, UK. The positions are office based but we can offer some flexibility to support your work-life balance.
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us.
As a Data Quality Manager within AstraZeneca's Clinical Trial Data Science group you will work at the heart of our Early Clinical Project Teams. Your proven data management expertise will be a key in supporting studies and projects, decision making and driving best practice from a Data Management perspective.
Early Clinical Biometrics is totally focused on delivering innovation, science and seeking out opportunity. This small, dynamic group is looking to expand and we are looking for passionate, innovative individuals to help develop, lead and shape the way we work. We are committed to supporting personal development and growth of individuals.
If you're inspired by the possibilities of science to make a difference and ready to discover what you can do - join us.
Main duties and responsibilities
* Provide clinical data management support to internal study teams in early clinical development, and project support to the Data Management Expert (DME).
* Communicate frequently and provide the right level of support to the lead data manager and other relevant functions at the vendor
* Actively participate in study team meetings and maintain awareness of the current status of the study
* Responsible for providing guidance on existing/new data standards
* Review of key clinical research documents
* Provide support, guidance and expertise to Data management activities
* Specialist in Therapy Area (TA) specific data capture and standards (Oncology, respiratory and cardiovascular) and CDISC standards
* Responsible for the data quality, risk mitigation and assessing solutions within studies
* Contribute to process development and improvement reviews, help define working practices and ensure non-compliant processes are escalated
Essential requirements
* BSc or post graduate qualification (or local equivalent) in computing, Life Sciences or equivalent experience
* Experience as a lead data manager
* Good knowledge of clinical database applications such as EDC
* Excellent communication skills
* Working knowledge of good clinical practice, Clinical research, Clinical trial processes and the related regulatory requirements and terminology
* Ability to demonstrate strong time management and team working skills
* Excellent customer focus and good client relationship skills
* High attention to detail and a strong analytical mind-set
Desirable requirements
* Therapy Area Experience from Oncology, respiratory and cardiovascular
* Experience as a lead of a large phase III trial or multiple smaller trials
* Experience of vendor management
* Experience on Early Clinical Development trials
* SAS programing/mapping of data to SDTM
* CDISC education
* Technical knowledge of EDC systems
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
Closing date: 31 May 2018
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2018-05-08ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2018-05-29
Ange följande referens när du ansöker: R-027662
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
ulrica.marklund1@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
43183
43183 1480
KontorsadressPepparedsleden 1
Jobbnummer 4132601
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