Lindus Health · 20 hours ago
Clinical Monitoring Manager
United States
Full-time
Remote
Senior LevelLindus Health is dedicated to transforming clinical trials to improve patient access to new treatments faster. They are seeking a Clinical Monitoring Manager to lead and innovate monitoring strategies across their clinical trials, ensuring patient safety and data integrity while mentoring a team of Clinical Research Associates.
BiotechnologyClinical TrialsHealth CareMedical
Responsibilities
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
Qualification
Required
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
$2,000 annual Learning & Development budget for courses, certifications, and conferences
$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
Company
Lindus Health
Lindus Health is an anti-contract research organization that conducts end-to-end clinical trials for the life sciences sectors.
Founded in 2021
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$79.55MKey Investors
ARIABalderton CapitalCreandum
2025-04-03Grant
2025-01-22Series B· $55M
2023-08-16Series A· $18M
Leadership Team
Michael Young
Co-CEO
Heather Davis
Vice President, Clinical Operations US
Recent News
2026-01-09
2026-01-09
FierceBiotech
2025-12-20
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