Manager, Biosample Operations
Listed on 2026-07-06
-
Research/Development
Regulatory Compliance Specialist, Clinical Research
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. The role is based in Santa Monica, CA, and reports to the Director, Translational Operations.
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 and traceability during transport; collaborate with the Clinical Operations team, Central Laboratories, and external vendors to troubleshoot issues related to sample collection, processing, storage, or shipment that could affect sample integrity and 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 tools 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.
- May manage contractors.
- BS with at least 5 years of relevant experience.
- MS with 4+ years of relevant experience.
- Excellent record‑keeping skills.
- Ability to simultaneously manage work across different clinical programs and prioritize planning of activities.
- Previous experience managing logistics and storage of biospecimens 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.
- Collaborative, team‑oriented, and adept at working across organizational interfaces.
- Experience with LIMS.
The anticipated salary range for candidates who will work in Santa Monica, CA is $ - $. The final salary offered will depend on factors such as length and type of experience, education, and industry experience.
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.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with a wide range of perspectives, and harnessing industry‑leading skills. We welcome and consider applications from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non‑discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
#J-18808-Ljbffr(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).