Study Operations Clinical Sample Scientist
Dfind Science & Engineering AB / Apotekarjobb / Göteborg
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hela Sverige Study Operations Clinical Sample Scientist
We can now offer an exciting 12 month consultant assignment at AstraZeneca in Gothenburg as they are looking for a Clinical Sample Scientist to join their Early Clinical Developement team.
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.
Tasks and responsibilities/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
Requirements:
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
Business: Dfind Science & Engineering
City: Gothenburg
Deadline for applications: 2018-12-06. 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: Malin Wåhlberg
malin.wahlberg@dfind.se or Birgitta Nyström
birgitta.nystrom@dfind.sePlease 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 second largest company within recruiting and staffing.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2018-11-30ErsättningFast lön
Så ansöker duSista dag att ansöka är 2018-12-10
Ange följande referens när du ansöker: 201188592
Klicka på denna länk för att göra din ansökanKontaktMalin Wåhlberg
malin.wahlberg@dfind.seFöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Södra Hamngatan 35
41110 GÖTEBORG
KontorsadressSödra Hamngatan 35, 41110 GÖTEBORG
Jobbnummer 4486825
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