Data Quality Manager to AstraZeneca Gothenburg

Poolia Väst AB / Apotekarjobb / Göteborg
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Here is a great opportunity for you if you would like to join AstraZeneca's journey in a challenging postion in a role as Data Quality Manager! Early Clinical Development is now looking for Life Science talent with data management experience. The 16-months consultant assignment will start as soon as possible. Next step, apply today!

Publiceringsdatum
2019-05-02

Om tjänsten
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.

Dina arbetsuppgifter i huvudsak
• 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

Vem är du?
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

Om verksamheten
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.

Varaktighet, arbetstid
Heltid Visstid, mer än 6 månader

Ersättning
Enbart provision

Så ansöker du
Sista dag att ansöka är 2019-05-16
Ange följande referens när du ansöker: 53062
Klicka på denna länk för att göra din ansökan

Kontakt
Jenny Lundkvist jenny.lundkvist@poolia.se 0720774415

Företag
Poolia Väst AB

Adress
Poolia Väst AB
Kungsgatan 42
41115 Göteborg

Kontorsadress
Kungsgatan 42

Jobbnummer
4763400

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