Manager, Biosample Operations

AstraZenecaSanta Monica, CA
Onsite

About The Position

At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. Position Summary The Manager, Biosample Operations will lead all aspects of the coordination and tracking of Human Biological Samples (HBS) and information from clinical trial patients across multiple clinical programs. You will work collaboratively within the Translational Sciences team and with teams in accomplishing such goals. This position is based in Santa Monica, CA, and reports to the Director, Translational Operations.

Requirements

  • BS with at least 7 years of experience or MS with 4+ years of relevant experience.
  • Excellent record keeping skills.
  • Simultaneously manage work in different clinical programs and prioritize planning of activities.
  • Previous experience managing logistics and storage of bio-specimens from clinical studies.
  • Familiarity with analytical methods and specimen requirements for assays commonly used in data generation for biomarker or pharmacokinetic analysis.
  • Management experience and management of partnered staff at external vendors.
  • Collaborate, work, and organizational interfaces in a dynamic team setting.
  • Experience with LIMS.

Responsibilities

  • Coordinate the logistics and tracking of HBS shipments from the clinical trial sites to the testing laboratories or third-party Contract Research Organizations (CROs).
  • Ensure sample integrity & traceability during transport. Collaborate with the Clinical Operations team and Central Laboratories and other external vendors to troubleshoot any issues occurred while sample collection, processing, storage, or shipment that could affect sample integrity. Help resolve queries in the CRO database.
  • Responsible for receipt, accessioning, and recording of samples sent for laboratory analysis.
  • Manage internal inventory storage and use of clinical samples.
  • Lead all aspects of and track sample analysis by external contractors ensuring that projects are completed and data is generated and transferred according to the agreed timelines.
  • Maintain patient dashboards/scheduling tool(s) used to provide traceability to completion of sample analysis and report generation.
  • Help develop and implement new sample tracking, record-keeping, and quality systems.
  • Support management of inventory storage and usage of reagents for clinical trial assays and assist with procurement tasks.

Benefits

  • Short-term incentive bonus opportunity
  • Equity-based long-term incentive program
  • 401(k) plan
  • Paid vacation and holidays; paid leaves
  • Health benefits including medical, prescription drug, dental, and vision coverage.
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