Data Quality Manager at AstraZeneca R&D Gothenburg
Dfind Science & Engineering AB / Apotekarjobb / Göteborg
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AstraZeneca is a major international healthcare business 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 2020-09-19.
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
Business Dfind Science & Engineering
City: Gothenburg Deadline for applications: 2019-05-11. Selection is on-going and interviews will be held continuously which means the position can be filled before deadline. Please make sure to send in your application at your earliest convenience!
For more information contact: Kerstin Karlsson
kerstin.karlsson@dfind.se or Malin Wåhlberg
malin.wahlberg@dfind.se Please keep in mind, e-mail applications will not be considered. Register your profile at Dfind Science & Engineering's webpage and send in your application there.
Organization/Business description: Dfind Science & Engineering is a recruitment and consulting company within science and engineering. All our consultant managers and recruitment consultants have an education and work experience within the respective field. In combination with extensive knowledge of staff issues and solid experience of recruitment, this means that we understand our clients' need for both flexibility and the right skills. Dfind Science & Engineering is since 2016 part of Randstad Group. With over 600 000 employees in over 40 countries Randstad is the world's largest company within recruiting and staffing.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2019-04-30ErsättningFast lön
Så ansöker duSista dag att ansöka är 2019-05-11
Ange följande referens när du ansöker: 201209139
Klicka på denna länk för att göra din ansökanKontaktMalin Wåhlberg
malin.wahlberg@dfind.seFöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Södra Hamngatan 35
41114 GÖTEBORG
KontorsadressSödra Hamngatan 35, 41114 GÖTEBORG
Jobbnummer 4760090
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