Sr. Manager, Clinical Site Operations

Karius•Redwood City, CA

10d•Hybrid

About The Position

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.

Requirements

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; experience with LDTs or in vitro diagnostic devices strongly preferred.
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.

Nice To Haves

CCRA/CCRP certification is desired.

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.