Data Quality Manager to AstraZeneca Gothenburg
Alten Sverige AB / Apotekarjobb / Göteborg
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hela Sverige About AstraZeneca
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 workin
• 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
About ALTEN
For over 20 years, ALTEN has developed its business by keeping to the core values that have built up the company's success. Every year, hundreds of ALTEN consultants have been given the opportunity to embark on challenging technical projects for our customers. ALTEN has a tradition of developing products in many areas, and history in Sweden is based primarily on skills in mechanics, software and electronics. Thanks to a successful concept in which we utilize the expertise of experienced consultants and develop young abilities towards a successful career, we have gained ground in many industries. Our Pharma initiative is based on the same successful concept with the same strong structure, but in a new exciting industry and a new field of expertise that includes knowledge in chemistry, biotechnology and biomedicine.
As an employee at ALTEN, we offer you a competitive salary based on your performance and work experience. You also have the opportunity to influence your assignments, different benefits and your overall working environment as well as choose your career path. We offer a wide range of internal trainings and an opportunity to plan for an international career. It is our conviction that genuine commitment is created through choice and the ability to influence your own personal development - our business model provides that opportunity. This freedom of choice enables us to offer our clients the most committed consultants, regardless of assignments. At ALTEN, we believe in growing together!
For questions about the position, please contact Matilda Holthe at
matilda.holthe@alten.seVaraktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2019-04-30ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2019-05-13
Klicka på denna länk för att göra din ansökanKontaktHR-avdelningen, Alten
FöretagAlten Sverige AB
AdressAlten Sverige AB
Theres Svenssons gata 15
41755 Göteborg
KontorsadressTheres Svenssons gata 15, Göteborg
Jobbnummer 4760330
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