Sr. Manager, Clinical Site Operations

About Karius

Karius is a life science, venture-backed clinical metagenomics company, focused on elevating patient care through microbial insights. We are committed to advancing diagnostic science and technology to optimize the diagnosis and treatment of infectious diseases. Through the use of genomics and AI, we are driven to improve the diagnostic landscape for infectious diseases. Karius delivers unprecedented diagnostic insight detecting microbial cell-free DNA circulating in the body to assist physicians to make rapid treatment decisions.

Leads and mentors a team of Clinical Research Associates (CRAs), and serves as the Clinical Operations site-level lead for assigned protocol(s), with end-to-end accountability for site strategy, selection, activation, performance, and close-out. This role is responsible for building and executing site management plans, ensuring adherence to clinical trial protocols, GCP regulatory requirements, and driving high-quality monitoring and data integrity across the study.

Accountable for CRA training and performance, proactive issue identification and resolution, review of monitoring deliverables for quality and trends, and partnering closely with the cross-functional clinical study team to ensure project milestones are achieved.

Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The company’s platform is already delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood, and helping industry accelerate the development of therapeutic solutions. The products Karius offers today are some of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients.

Our tests are the result of some incredible work done by our scientists, statisticians, engineers, and physicians, all driven by the same mission. You, as part of the Karius team, will be able to see how directly your work has a life-changing impact on people, and at scale.

Reports to:

Director, Clinical Operations

Location:

Redwood City, CA (Hybrid) or Remote (USA)

• Owns and executes site identification, feasibility, and selection strategy in partnership with Clinical Development and other stakeholders.
• Develops and maintains site feasibility tools (questionnaires, scoring, prioritization criteria) aligned with protocol needs.
• Leads feasibility outreach, evaluates investigator/site capabilities (patient access, competing trials, staffing, lab/diagnostic readiness), and recommends final site list.
• Oversee site management and continuously assess study performance, ensuring adherence to timelines and quality expectations.
• Lead Site Initiation Visits with strong, clear communication to set expectations and align site staff on study requirements.
• Accountable for site startup timelines and deliverables, including SIV readiness, regulatory collection, and activation decision-making.
• Tracks and unblocks CTA/budget execution, IRB/EC approvals, and essential document completeness.
• Ensures sites are trained on protocol, systems, and study workflows; confirms training completion and readiness for first subject first visit (FSFV).
• Oversees creation and execution of site activation plans with clear critical path, milestones, and risk mitigations.
• Establishes site performance expectations and KPIs (activation, enrollment, data quality, responsiveness, protocol adherence).
• Monitors performance dashboards and trends; leads remediation and escalation plans for underperforming or at-risk sites.
• Facilitates regular site touchpoints (e.g., monthly calls, recruitment reviews) to sustain momentum and troubleshoot barriers.
• Drives enrollment optimization strategies and supports sites with recruitment toolkit/materials as applicable.
• Conduct monitoring visits at assigned sites as needed to support quality, compliance, and enrollment goals.
• Lead and mentor the CRA team, hold regular meetings, and provide day to day guidance to drive efficiency,…