Lindus Health

Clinical Monitoring Manager

Lindus Health

full-time

Posted on:

Location Type: Remote

Location: United States

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About the role

  • Own Lindus Health's approach to clinical trial monitoring across our portfolio. Design and oversee risk-based, proportional monitoring strategies for each trial, determining what to monitor, how frequently, and with what intensity. Challenge traditional monitoring assumptions and ensure we're consistently applying the right level of oversight to protect patients and data integrity without unnecessary burden.
  • Provide line management and coaching to our CRA team, building their capability to think critically about monitoring rather than simply following scripts. Set clear expectations, ensure accountability and follow-through after monitoring visits, and develop less experienced CRAs on best practices, proportionality, and taking initiative.
  • Conduct on-site and remote monitoring visits as needed to support the team during peak periods, cover complex or high-risk trials, or model best practices for the CRA team. Maintain your clinical monitoring skills and stay connected to the practical realities of site-level work.
  • Represent monitoring strategy in bid meetings and sponsor conversations. Confidently propose and defend creative, risk-based monitoring approaches, explaining why Lindus monitors differently and how our approach benefits trial quality and efficiency. Build sponsor trust in our monitoring capabilities.
  • Act as the monitoring voice into our product and technology teams, particularly for our Citrus platform. Translate monitoring requirements into clear, lay-term product needs, drawing on your experience with other EDC and monitoring systems. Ensure our technology supports compliant, efficient monitoring workflows and identify opportunities for innovation.
  • Work collaboratively with UK/EU Clinical Operations teams to develop and maintain consistent monitoring standards and processes across regions, while allowing for appropriate local flexibility.
  • Spot patterns across trials, identify areas for improvement in our monitoring approach, and drive implementation of new processes or tools. Stay current on regulatory expectations and industry best practices in risk-based monitoring.

Requirements

  • You have deep clinical monitoring expertise. You've worked as a CRA or in a closely related Clinical Operations role (e.g., Clinical Trial Manager, Project Manager, Quality/QA focused on monitoring) and have moved beyond executing site visits to designing and overseeing monitoring strategies across multiple trials. You're comfortable staying hands-on with monitoring visits when needed.
  • You're a strategic thinker about risk-based monitoring. You have strong experience with risk-based and proportional monitoring approaches: you understand how to identify what matters most for patient safety and data quality, and you can tailor monitoring intensity accordingly.
  • You've thrived in innovative, agile environments. Ideally, you come from a biotech, smaller CRO, or similarly innovative setting where you've had to think creatively and adapt quickly. You're comfortable with ambiguity, changing priorities, and pushing for new ways of working rather than just following established playbooks.
  • You aspire to be a people leader. You have experience coaching CRAs or similar roles, providing clear accountability while developing their skills and encouraging initiative and critical thinking.
  • You're a confident communicator and influencer. You can explain complex monitoring concepts in simple terms to diverse audiences, from sponsors to internal cross-functional teams. You're comfortable representing monitoring strategy in bid meetings and defending your approach with evidence and clear rationale.
  • You can translate clinical needs into product requirements. You've worked with EDC systems and monitoring tools, and you can articulate what functionality is needed to support compliant, efficient monitoring, even to non-clinical audiences.
  • You value collaboration across time zones. You're willing to work closely with UK/EU teams to ensure consistency of monitoring standards and approaches globally.
Benefits
  • Competitive salary plus meaningful equity: you'll own a piece of what we're building
  • $2,000 annual Learning & Development budget for courses, certifications, and conferences
  • 39 days annual leave (27 days PTO + 11 federal holidays + 1 James Lind Day)
  • $800 monthly employer contribution for insurance coverage (via Trinet PEO)
  • $40 monthly wellness allowance with flexibility on how to spend this, including opting in to a company private health insurance or Wellhub membership
  • Access to gym and retail discounts through Happl
  • Monthly lunch vouchers for remote team members
  • Regular company events and team gatherings (both virtual and in-person)
  • Charity partnerships and volunteering opportunities with Forward Trust
  • Work with a team that's genuinely changing healthcare for the better
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical trial monitoringrisk-based monitoringproportional monitoringmonitoring strategy designsite visitsclinical operationsEDC systemsmonitoring toolsdata quality assurancepatient safety
Soft Skills
strategic thinkingcoachingaccountabilitycritical thinkingcommunicationinfluencingcollaborationadaptabilityproblem-solvingleadership