Study Operations Clinical Sample Scientist

We’re currently looking for a Clinical Sample Scientist to join a dynamic Early Clinical Development team based in Gothenburg, Sweden. The 12-months consulting assignment will start in january 2019 after agreement. If you are interested, apply now!

About the consulting assignment
The Arena:
At AstraZeneca, innovation is more than just research. As one of the world's leading pharmaceutical companies, we’re focused on providing medicines that make a real difference in patient care. The role is based within the Study Operations department in ECD and requires an understanding of laboratory testing to effectively manage our external laboratory suppliers. In this role, you will support the delivery of laboratory related activities in both early and late phase global development studies. You will work closely with our internal or external study teams, our global external laboratory partners and alliances and the clinical study teams to ensure operational delivery of the clinical laboratory testing of biological samples, the efficient deployment of tests (including biomarkers, central safety and clinical bioanalysis), as well as data generation and delivery throughout the study lifecycle. This is a fantastic opportunity to progress your career into Clinical development and to play a key role in the execution of studies that will change the lives of patients’ worldwide.

The role:
The Clinical Sample Scientist is responsible for ensuring operational management of Clinical laboratory collection and testing of human biological specimens and the efficient operational deployment of such clinical laboratory testing (including biomarkers, central safety testing and clinical bioanalysis for pharmacokinetic assessment). The scope covered by the Clinical Sample Science covers all clinical trial activities regardless of phase and similarly may be deployed to GMD, GMA or Affiliate Projects. Your position will be varied and include the responsibility for ensuring all externalised laboratory activities meet internal and external quality and regulatory standards, whilst using your operational expertise to advise clinical teams on operational lab strategy, development and deployment. You will regularly be involved in providing advice to clinical teams on laboratory related documentation, operational design and new ways of working such as. CRFs, ICFs, sample collection and distribution, as well as managing external providers to oversee the delivery of relevant lab services and data.

Typical Accountabilities:
• Provide appropriate operational contribution to the inclusion of laboratory testing of human biological specimens into clinical programmes and trials
• Ensure all the laboratory components within planning operational delivery documents are accurate and fit for purpose
• Oversee delivery of laboratory services and data from external providers at a study level
• Provide business oversight of external laboratory budgets at a study level
• Provide rapid, regular and frequent updates of all activities to senior management within R&D and other functions within AstraZeneca as required
• Contribute to clinical laboratory training & education and to maintenance of relevant SOPs, guidelines, and templates
• Support clinical study teams in the delivery of laboratory requirements

About you
To be considered for this position it is expected that you have a good understanding of clinical or pre-clinical drug development, as well as of GCP and GCLP. In addition to this, the following experiences are desirable;

• Experience of working collaboratively with external vendors in partnerships or alliances
• Experience of working in a global setting
• Hands-on experience in a clinical laboratory setting or clinical research site
• Project management experience
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. At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing.
Warmly welcome with you application!

Varaktighet 6 månader eller längre
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