Manager, Biosample Operations

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Position Summary

The Manager, Biosample Operations will oversee 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. You will be based in Santa Monica, CA, and report to the Director, Translational Operations.

Responsibilities

• Oversee the logistics and tracking of HBS shipments from the clinical trial sites to our 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.

• Oversee 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.

• Help with other responsibilities to meet corporate goals.

• May manage contractors.

Education and Experience

• 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 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.

• Collaborate, work, and organizational interfaces in a dynamic team setting.

• Experience with LIMS.

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The annual base pay for this position $105,875 to $158,812.Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 

DE&I Statement

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team 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.