Biobank Manager at Karius
Redwood City, CA, US

Karius is a venture-backed life science startup focused on transforming the way infectious diseases are diagnosed.  Combining Next-Generation Sequencing and proprietary data analysis, we can identify over 1,000 pathogens from a single blood sample with typical turnaround time in one business day. By unlocking the information present in microbial cell-free DNA, we're helping doctors quickly solve their most challenging cases, with a future vision of accelerating clinical trials, discovering new microbes, and reducing patient suffering worldwide.
Position Summary
Karius is on a mission to help clinicians do more for their patients by bringing the genomic revolution to infectious disease diagnosis. The Biobank Manager reports to the Director of Clinical Operations. We are looking for an experienced self-motivated, critical thinker that can work independently within a high performing clinical operations team. In this role, the Biobank Manager is responsible for specimen banking and procurement from both clinical sites and vendors to support necessary business goals that drive the adoption of Karius’ novel diagnostic technology within specific clinical indication(s).
Reports to          Director, Clinical Operations
Location             Redwood City, CA

·       Acts as the operational focal point and works with clinical and product teams to plan, organize and execute the handling and management of samples from large scale, prospective studies and commercial vendors
·       Provide leadership of biosample strategy across multiple clinical programs and ensure its execution in accordance with the requirements of quality, ethical and regulatory guidelines, including ICH/GCP/GLP
·       Establish, implement, and maintain processes for sample management, including SOP development across all Karius studies
·       Seamlessly execute all contracting and payments associated with sample banking/procurement
·       Establish, implement, and maintain an effective sample inventory and tracking software
·       Develop study-specific sample management plans and documentations, including vendor agreements, vendor qualification documents, site training materials, and training materials for site personnel performing sample collection, processing, and shipping
Ensure that all sample acquisition efforts are harmonized with project timelines and mitigate against delays
·       Develop reporting tools representing metrics and trends related to samples and state of clinical programs and present to study teams and management teams, as needed
·       Consistently supports compliance and the principles of Karius’s mission by maintaining the privacy and confidentially of information, acts with ethics and integrity, reporting non-compliance, and adhering to applicable federal, state and local laws and regulations, accreditation and license requirements and company policies and procedures
·       Mentor peers and junior associates, as requested
Travel: Travel required 5-10%
Physical Requirements:
Work is generally performed in laboratory area and office. Subject to extended periods of sitting and/or standing, computer work and moderate noise levels.

Position Requirements:
·            Bachelor’s Degree in scientific or health related field or equivalent years of experience
·            5+ years’ experience managing biosample operations activities for large, complex, multi-center clinical studies
·            Experience with project, vendor, contract, and site management
·            Advanced knowledge of ICH/GCP/GLP and best practices in biobanking
·            Experience with Institutional Review Board (IRB) preparations and submissions
·            Experience writing, reviewing and editing sample collection protocols
·            Proven ability to both bank and fulfill other strategic responsibilities in tandem
·            Must demonstrate ability to scale programs
Personal Qualifications:
·       Must be an excellent communicator and able to balance complex strategic and operational initiatives including legal/policy and business issues
·       Ability to anticipate and identify potential roadblocks to meeting goals and identify corrective actions
·       Excellent written and verbal communication skills, including ability to effectively present information and respond to questions from project teams, sites and external vendors
·       Must be able to work in a collaborative environment and consistently demonstrate knowledge, skills, abilities and behaviors necessary to provide high quality service to both internal and external stakeholders
·       Ability to prioritize and manage deadlines
·       Display a high level of commitment and professionalism and is truly passionate about being in the cutting edge of science to help support generate the appropriate clinical evidence