Sr. Manager, Clinical Site Operations

Redwood City, CA - USA

Monthly Salary: Not Disclosed

Posted on: 6 days ago

Vacancies: 1 Vacancy

Job Summary

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.

Position Summary

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.

Why Should You Join Us

Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The companys 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)

Primary 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.

Whats Fun About the Job

Karius is operating at the edge of what is now known to be possible in diagnostics. With that comes a wave of new and incredible challenges and opportunities. To deliver on that value you will be tapping into some of the most advanced technologies architecting and innovating where the current solutions simply dont suffice. You will get to see how much your work really matters.

Travel: up to 60% within the United States.

Physical Requirements

Subject to extended periods of sitting and/or standing vision to monitor and moderate noise levels. Work is generally performed in an office lab or clinical environment.

Position Requirements

Bachelors 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.

CCRA/CCRP certification is desired.

Personal Qualifications

This position requires excellent communication and interpersonal skills attention to detail and advanced problem solving.

Disclaimer

The above job description is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties responsibilities and skills required. Responsibilities and duties may change or be adjusted to meet the needs of the company and additional duties may be assigned as necessary. The job description is subject to change at any time at the discretion of Karius.

Equal Opportunity Employer

At Karius we value a diverse and inclusive workplace and provide equal employment opportunities for all applicants and employees and are committed to honor and invest in the full diversity of people in our hiring recruiting and development of employees across the Company. All qualified applicants for employment are encouraged to apply and will be considered without regard to an individuals race color sex gender identity and gender expression (including transgender individuals who are transitioning have transitioned or are perceived to be transitioning to the gender with which they identify) religion age national origin or ancestry citizenship physical or mental disability medical condition family care status marital status domestic partner status sexual orientation genetic information military or veteran status or any other basis protected by federal state or local laws. If you are unable to submit your application due to a disability please contact us at emailprotected and we will accommodate qualified individuals with disabilities.

$147754 - $221632 a year

Required Experience:

Manager

About KariusKarius 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 ...