Karius · 1 month ago
Sr. Manager, Clinical Site Operations
United States
Full-time
Remote
Senior Level, Lead/Staff
$148K/yr - $222K/yr
8+ years expKarius is a life science company focused on advancing diagnostic science and technology to optimize the diagnosis and treatment of infectious diseases. The Sr. Manager, Clinical Site Operations will lead and mentor a team of Clinical Research Associates, ensuring adherence to clinical trial protocols and driving high-quality monitoring and data integrity across studies.
BiotechnologyGeneticsHealth CareInformation TechnologyLife SciencePrecision Medicine
Responsibilities
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, consistency, and high quality execution
Ensure all monitoring activities follow the Clinical Monitoring Plan, ICH GCP guidelines, and applicable local regulations
Review monitoring visit reports, data metrics, and protocol deviations to identify trends, risks, and opportunities for corrective or preventive action
Oversees management of protocol deviations, violations, and consent noncompliance; partners with QA/Medical as needed
Ensures inspection readiness at site and study levels; supports audits and inspections, including prep and follow-up actions
Contribute to the creation of training materials and train CRAs on study specific requirements, reinforcing compliance with all protocols and procedures
Address study specific questions, troubleshoot operational challenges, and manage escalations to resolution in a timely manner
Partner and support the Clinical Trial Manager (CTM) to provide operational expertise, status updates, and insight into study progress, risks, and obstacles
Ensure sites maintain complete and current Investigator Study Files and remain inspection ready at all times
Qualification
Required
Bachelor's degree in a life sciences or health-related field required
Proven success in multi-site management
8+ years of clinical trial experience to include study monitoring
3-5 years of personnel management experience
Strong knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial operations
Ability to travel frequently, sometimes on short notice, and manage travel logistics effectively
Proficiency in Microsoft Office and clinical trial management systems (CTMS) required
Preferred
Experience with LDTs or in vitro diagnostic devices strongly preferred
CCRA/CCRP certification is desired
Company
Karius
Karius delivers genomic insights into infectious diseases, helping clinicians make critical, life-saving treatment decisions.
51-200 employees
H1B Sponsorship
Karius has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2021 (4)
Funding
Current Stage
Growth StageTotal Funding
$354MKey Investors
SoftBank Vision FundOxford Finance LLCDCVC
2024-05-02Series C· $100M
2020-02-24Series B· $165M
2018-11-30Debt Financing· $25M
Leadership Team
Alexander Ford
Chief Executive Officer
Tim Blauwkamp
Chief Scientific Officer, Co-founder
Recent News
General Catalyst
2026-01-06
2025-05-04
Company data provided by crunchbase