Clinical Trial Manager

Foresight Diagnostics Inc. • Aurora, CO

2d • Remote

About The Position

The clinical studies at Foresight Diagnostics are crucial for bringing their MRD detection technology to patients and oncologists. They are seeking a Clinical Trial Manager to ensure complex studies stay on track, manage partner relationships, and demonstrate a personal investment in precision oncology. Foresight Diagnostics is a molecular diagnostics company that pioneers non-invasive cancer detection using highly sensitive, cell-free DNA-based liquid biopsy technologies, originally developed at Stanford University. Their methods aim to detect smaller tumors earlier and enable personalized treatment strategies for cancer patients. The company operates at the intersection of molecular biology, bioinformatics, and next-generation sequencing (NGS), translating rigorous science into clinical solutions. Following its acquisition by Natera, Foresight Diagnostics combines startup agility with the resources of a global leader in cell-free DNA testing. Headquartered in Boulder, Colorado, the team emphasizes high accountability, collaboration, quality, and continuous improvement. The clinical portfolio is expanding to include companion diagnostic studies, investigator-initiated studies, and internally sponsored programs. Each program requires a dedicated operational owner to manage the full study lifecycle from start-up through reporting, ensure quality and compliance, and serve as the primary interface with biopharmaceutical and research institution partners. This role reports to the Director of Clinical Operations and is central to the cross-functional clinical team, collaborating daily with the clinical laboratory, bioinformatics, regulatory, medical affairs, and operations functions. The work is fast-paced, detail-oriented, and directly impacts the commercial and scientific direction of the MRD platform.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.
• Implement and maintain primary accountability for clinical study protocols and operational plans aligned with corporate strategic objectives.
• Manage day-to-day study operations in compliance with GCP/ICH guidelines and applicable regulatory requirements.
• Coordinate study timelines across cross-functional teams to hit critical milestones, proactively identify and resolve issues before they become blockers, and manage escalation when needed.
• Provide oversight and direction to study team members (CRAs, Project Coordination) on study deliverables and performance.
• Train partners, sites, and internal team members on study protocols, operational plans, and applicable guidelines and regulations.
• Co-develop and manage study materials through their full lifecycle- protocols, operational plans, and applicable guidelines and regulations.
• Oversee the eTMF to ensure ongoing compliance and inspection readiness.
• Lead assigned internal and partner meetings, developing agendas, curating and filing minutes, and maintaining detailed dashboards and progress trackers that keep all stakeholders clearly informed.
• Support process improvement initiatives and serve as a subject matter expert and mentor within the clinical operations function.

Benefits

• Medical, dental, and vision
• Flexible PTO and paid holidays
• Parental leave
• 401(k) with company match
• Professional development of our teams and encourage upward mobility within the company for high performing employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level