Clinical Monitoring Manager

Lindus Health

10d•Remote

About The Position

We're looking for a Clinical Monitoring Manager to join our Clinical Operations team and transform how we approach monitoring across our portfolio of innovative clinical trials. This is a unique opportunity to build and lead our monitoring strategy from the ground up: you won't just execute monitoring plans, you'll define how monitoring should be done at Lindus Health on a global level. As our monitoring subject matter expert, you'll design risk-based, proportional monitoring approaches that challenge traditional CRO thinking. You'll lead and develop our CRA team, ensuring they're not just checking boxes but thinking critically about what proportional monitoring activities truly protect patient safety and data integrity. You'll also be a key voice in sponsor conversations, confidently proposing creative monitoring strategies and explaining why we monitor differently, and better. This role uniquely combines strategic oversight, hands-on global team leadership, and cross-functional collaboration, including working closely with our product team to ensure our technology platform (Citrus) supports efficient, compliant monitoring. While primarily focused on strategy and team leadership, you'll also stay hands-on with monitoring, conducting site visits yourself when needed during peak periods, for complex trials, or to model best practices for your team. You'll shape the future of monitoring at Lindus Health while mentoring the next generation of CRAs. This is a fully remote position based in the United States, ideally in EST or Central time zones.

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.

Responsibilities

Monitoring Strategy & Subject Matter Expertise: 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.
CRA Team Leadership & Development: 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.
Hands-On Monitoring: 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.
Sponsor-Facing Communication & Business Development Support: 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.
Cross-Functional Collaboration & Product Development: 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.
Global Monitoring Standards: 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.
Continuous Improvement & Innovation: 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.

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