Sr. Biosample Manager

Nurix•Brisbane, CA

12d•Onsite

About The Position

Nurix Therapeutics, Inc. is seeking a Sr. Biosample Manager to join the Clinical Operations team. This is an onsite role. This individual will work cross functionally, with both internal and external stakeholders, to plan, coordinate, and oversee all operational activities required to manage the lifecycle of the clinical biosamples and support translational research.

Requirements

B.S. in biological sciences with 8+ years of relevant industry experience
Knowledge of FDA, ICH/GCP, and GDPR regulations and guidelines
Proven track record of sample management, data management and vendor management skills
Developed central lab specifications and logistics for global studies at study start or protocol amendments with cross-functional collaboration
Ability to develop and manage workflows and data sets
Proficiency in MS Office including with advance Excel skills
Good initiative and ability to work independently
Ability to work in a fast-paced environment
Excellent written and interpersonal communication skills
Detail oriented with the ability to manage multiple competing priorities
Effective team player and ability to collaborate with cross functional clinical study teams

Responsibilities

Provide guidance during protocol and informed consent form development to ensure logistical feasibility of biosample handling, alignment with planned analyses and ICH/GCP compliance
Participate in the CRF development process to ensure that biosample information is appropriately captured for sample tracking and reconciliation purposes
Serve as the functional lead as a member of the Clinical Study Teams and provide regular biosample metrics/trends and status updates
Partner with cross-functional teams to ensure timely delivery of biosample data to meet publication and study goals
Provides operational leadership on vendor and sample management activities, including design of central lab specifications at study start or amendments
Oversee kit design, sample processing, and sample logistics to ensure that the investigator sites can meet the sample handling needs of the study
Plan, coordinate and oversee sample shipments and query resolution at laboratory vendors
Manage the sample management system to track the life cycle of the samples, identify trends and gaps, and support sample reconciliation
Provide training and guidance to the investigator sites and study monitors for biosample collection, handling and shipment
Manage laboratory vendors, overseeing vendor selection, technology transfers, budgets, contract management, and data management
Develop and maintain biosample operations SOPs and WPs