We are, on behalf of our customer Astra Zeneca in Gothenburg looking for a Study Operations Clinical Sample Scientist. Please state ref. 750083 if you respond to this request.
This consultant assignment is for 12 month starting in January 2019.
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.
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.
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