Clinical Trial Manager

Location: Boulder, CO · Full-Time · Remote

The clinical studies we run at Foresight Diagnostics are the pathways through which our MRD detection technology reaches the patients and oncologists who need it. We’re looking for a Clinical Trial Manager who brings the operational rigor to keep complex studies on track, the interpersonal fluency to manage demanding partner relationships, and the personal investment in precision oncology that makes this kind of work more than a job.

ABOUT FORESIGHT DIAGNOSTICS

Foresight Diagnostics is a molecular diagnostics company pioneering non-invasive cancer detection through highly sensitive, cell-free DNA-based liquid biopsy technologies. Our proprietary methods - originally developed at Stanford University - are designed to detect smaller tumors earlier and enable more personalized treatment strategies for patients with cancer.

We sit at the intersection of molecular biology, bioinformatics, and next-generation sequencing (NGS), and we translate rigorous science into clinically meaningful solutions. Following our acquisition by Natera, we now combine the agility of a mission-driven startup with the scale and resources of a global leader in cell-free DNA testing. It’s an exciting moment to join us.

Headquartered in Boulder, Colorado, our team operates in a high accountability, collaborative environment where quality and continuous improvement aren’t just values - they’re how we work every day.

WHY THIS ROLE EXISTS

Foresight Diagnostic’s clinical portfolio is growing, spanning companion diagnostic studies, investigator-initiated studies, and internally sponsored programs. Each requires a dedicated operational owner who can manage the full study lifecycle from start-up through reporting, maintain quality and compliance at every step, and serve as the primary interface between Foresight and its biopharmaceutical and research institution partners.

This role reports to the Director of Clinical Operations and sits at the center of our cross-functional clinical team, collaborating daily with the clinical laboratory, bioinformatics, regulatory, medical affairs, and operations functions. The work is fast-moving, detail-intensive, and directly connected to the commercial and scientific trajectory of our MRD platform.

WHAT YOU’LL DO

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. Specifically:

• 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.

WHAT YOU’LL BRING

Required

• 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.

Preferred

• Direct experience in precision oncology, MRD detection, or liquid biopsy clinical programs.

• Familiarity with companion diagnostic development pathways and co-development partnerships with biopharmaceutical companies.

• Experience with eTMF platforms and clinical trial management systems (CTMS).

• Background supporting regulatory submissions from a clinical operations documentation standpoint.

WHY JOIN US

The team you’d be joining takes both the science and the operational craft seriously. Clinical operations here means real ownership, and you’ll work alongside regulatory, bioinformatics, and lab colleagues who bring the same level of investment to their work. We offer flexible work arrangements, promote from within, and are at a stage where the right people have genuine influence over how the function grows.

COMPENSATION, BENEFITS & EQUAL OPPORTUNITY

This role offers a competitive annual base compensation of $150,000 - $170,000 commensurate with experience, and a comprehensive benefits package including:

• Medical, dental, and vision

• Flexible PTO and paid holidays

• Parental leave

• 401(k) with company match

You will be working on interesting problems with extremely high impact. We promote the professional development of our teams and encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Ready to make an impact in cancer diagnostics?

Apply below - we’d love to hear from you.