Data Quality Manager
Modis Sweden AB / Apotekarjobb / Göteborg
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hela Sverige Modis is now looking for a Data Quality Manager to AstraZeneca in Gothenburg. This is a consultancy assignment for 12 months, start spring 2019. Deadline for application is March 24.
AstraZeneca is a major international healthcarebusiness engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
The role:
The role of Data Quality Manager (DQM) is to be a member of the AZ study team accountable for the data quality of the studies assigned in Early Clinical Development. The DQM will give guidance in data management processes and related activities to the ECD study teams; provide expertise in data management as well as information on AZ standards, processes, systems and expectations to the vendor. The role is key to enabling efficient, timely and high-quality data delivery, in close cooperation with the vendor. The DQM will also be involved in process development and improvement initiatives. The DQM is responsible for the quality of their own work and will be expected to manage their own daily planning. High attention to detail and a strong analytical mind-set is essential.
This is a temporary assignment lasting until 2020-04-20.
Typical Accountabilities:
• 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
• Work within established frameworks to deliver a variety of tasks that support projects in meeting their objectives
• 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
• Responsible for submitting any new/amended standards and request for LAB codes in line with ECD processes
• Review of key clinical research documents (e.g. Study synopsis, Protocols, Case Report Forms, DMP, SAP etc)
• Provide support, guidance and expertise to Data management activities (. e.g. electronic data capture, data transfer agreements, SDTM mapping, AZ specific coding, data transfer agreements, reconciliation issues.)
• Specialist in 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 noncompliant processes are escalated
Minimum requirements:
• BSc or post graduate qualification (or local equivalent) in computing, Life Sciences or equivalent experience
• At least 5 years data management and/or related work in pharmaceutical company or CRO
• 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
• Truth seeking rather than success seeking
• Open to constructive feedback
• Excellent customer focus and good client relationship skills
• Demonstrate high attention to detail and flexibility in way of working.
• Excellent analytical and problem-solving skills
Preferred experience and key factors:
• TA 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
Send your application as soon as possible. For questions, please contact: Cecilia Larzon (
cecilia.larzon@modis.se)
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2019-03-19ErsättningFast lön
Så ansöker duSista dag att ansöka är 2019-03-25
Klicka på denna länk för att göra din ansökanKontaktCecilia Larzon
FöretagModis Sweden AB
AdressModis Sweden AB
Postgatan 28
41110 Göteborg
KontorsadressPostgatan 28
Jobbnummer 4677587
Observera att sista ansökningsdag har passerat.