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Sr. Manager, Clinical Site Operations

2 hours, 3 minutes ago
United States
Full-time
Lead
Operations Manager
Project and Program Management
GCP
Apply Now
Karius

Karius

Karius is a life sciences company revolutionizing infectious disease diagnostics with the Karius Test™, a non-invasive liquid biopsy detecting over 1000 pathogens from a single blood sample.

Pharmaceuticals
51-250
Founded 2014
$254M raised
View All Jobs 6

Description

  • Own site identification, feasibility, and selection strategy in partnership with Clinical Development and other stakeholders.
  • Develop and maintain site feasibility tools and criteria aligned with protocol needs.
  • Lead feasibility outreach, evaluate investigator and site capabilities, and recommend the final site list.
  • Oversee site startup, activation, and management timelines, including regulatory collection, CTA/budget execution, and IRB/EC approvals.
  • Lead Site Initiation Visits and ensure sites are trained on protocol, systems, workflows, and readiness for FSFV.
  • Establish and track site performance expectations and KPIs, and drive remediation for underperforming or at-risk sites.
  • Facilitate regular site touchpoints and support enrollment optimization efforts.
  • Conduct monitoring visits as needed to support quality, compliance, and enrollment goals.
  • Lead and mentor the CRA team, providing day-to-day guidance, training, and performance oversight.
  • Review monitoring reports, data trends, and protocol deviations; support inspection readiness, audits, and issue escalation to resolution.

Requirements

  • Bachelor's degree in a life sciences or health-related field required.
  • 8+ years of clinical trial experience, including study monitoring.
  • Experience with LDTs or in vitro diagnostic devices strongly preferred.
  • 3-5 years of personnel management experience.
  • Proven success in multi-site management.
  • Strong knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial operations.
  • Proficiency in Microsoft Office and clinical trial management systems (CTMS) required.
  • Ability to travel frequently, up to 60% within the United States, sometimes on short notice.
  • CCRA or CCRP certification is desired.
  • Excellent communication and interpersonal skills, attention to detail, and advanced problem-solving ability.

Benefits

  • Hybrid work in Redwood City, CA or remote work within the USA.
  • Salary range of $147,754 - $221,632 per year.
  • Opportunity to work on diagnostics and technologies aimed at improving infectious disease care.
  • Meaningful work with direct impact on patient care at scale.
  • Equal opportunity employer committed to diversity and inclusion.

Interested in this position?

Apply directly on the company website

Apply Now

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