Clinical Trial Manager

Foresight Diagnostics Inc.

. You’ll own the day-to-day operational execution of assigned clinical studies and be accountable for quality, timelines, and partner relationships from protocol implementation through close-out.

Posted 4/20/2026full-timeRemote • Colorado • 🇺🇸 United StatesMid-LevelSenior💰 $150,000 - $170,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

You’ll own the day-to-day operational execution of assigned clinical studies and be accountable for quality, timelines, and partner relationships from protocol implementation through close-out.
Implementing and maintaining primary accountability for clinical study protocols and operational plans aligned with corporate strategic objectives.
Managing day-to-day study operations in compliance with GCP/ICH guidelines and applicable regulatory requirements.
Coordinating study timelines across cross-functional teams to hit critical milestones, proactively identifying and resolving issues before they become blockers, and managing escalation when needed.
Providing oversight and direction to study team members (CRAs, Project Coordination) on study deliverables and performance.
Training partners, sites, and internal team members on study protocols, operational plans, and applicable guidelines and regulations.
Co-developing and managing study materials through their full lifecycle- protocols, operational plans, and applicable guidelines and regulations.
Overseeing the eTMF to ensure ongoing compliance and inspection readiness.
Leading assigned internal and partner meetings, developing agendas, curating and filing minutes, and maintaining detailed dashboards and progress trackers that keep all stakeholders clearly informed.
Supporting process improvement initiatives and serving as a subject matter expert and mentor within the clinical operations function.

Requirements

What you’ll need

5+ years of clinical trial experience in the biopharmaceutical or diagnostic industry, or at an academic medical center.
3+ years leading project operational teams through the full study lifecycle, start-up, conduct, data management, and report writing/review.
Experience working at or with a CRO, lab vendor, or biopharmaceutical company.
Solid working knowledge of Good Clinical Practices and all applicable U.S. regulations governing clinical research, with current GCP training documentation.
Working knowledge of the FDA submission process including IDE, PMA, and 510(k).
International study experience and familiarity with GDPR implementation.
Experience managing complex clinical data sets, including genomic data.
A self-starting, ownership-oriented approach - you don’t wait to be told what needs attention.
Exceptional organizational skills and the ability to manage multiple concurrent priorities without dropping the details.
Outstanding verbal and written communication skills, including strong email responsiveness and a genuine customer-service orientation towards partners and sites.
Proficiency in Microsoft Office suite.
Bachelor’s degree or equivalent in a scientific field, or an equivalent combination of education, training, and experience.

Benefits

Comp & perks

Medical, dental, and vision
Flexible PTO and paid holidays
Parental leave
401(k) with company match

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical trial experienceproject managementdata managementreport writingGood Clinical Practices (GCP)FDA submission processIDEPMA510(k)genomic data management

Soft Skills

organizational skillscommunication skillscustomer service orientationproblem-solvingleadershipmentoringself-startingownership-orientedattention to detailproactive issue resolution

Certifications

current GCP training documentation