Position: Biosample Manager
Nurix Therapeutics, Inc. is seeking a 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.
Responsibilities
Study Management
* 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
Biosample and Vendor Management
* 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
Qualifications
* 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 advanced 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
* Onsite role
Salary Range
140K - 180K plus equity and bonus
Equal Opportunity Employer
Nurix is an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US.
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