Foresight Diagnostics Inc. is hiring a Clinical Study Manager

Foresight Diagnostics is hiring a Clinical Study Manager to oversee, execute, and report on clinical study operations for our research projects. This role ensures studies are executed with quality and efficiency according to timelines and budget, involving study start-up planning, study conduct, site management, and collaboration with biopharmaceutical partners.

What You'll Do

• Implement and assume primary accountability for clinical study protocols and operational plans.
• Manage day-to-day study operations to ensure compliance with applicable GCP/ICH guidelines and regulations.
• Coordinate clinical study timelines with cross-functional teams to meet critical milestones.
• Provide oversight and direction to study team members including Clinical Research Associates and Project Coordinators.
• Train partners, sites, and internal team members on study protocols, plans, and regulations.
• Co-develop and manage study materials, including plans, protocols, informed consents, and data collection forms.
• Oversee the eTMF to ensure compliance and inspection readiness.
• Lead assigned meetings, including agenda development and minutes curation.
• Support process improvement initiatives and serve as a subject matter expert or mentor.

What We're Looking For

• Bachelor’s degree or equivalent in a scientific field.
• 5+ years of clinical trial experience in biopharmaceutical, diagnostic, or academic medical center settings.
• 3+ years of experience leading project teams through study start-up, conduct, data management, and reporting.
• Good knowledge of Good Clinical Practices and all applicable U.S. regulations governing clinical research.
• Working knowledge of the FDA submission process including IDE, PMA, and 510(k).
• Experience handling complex clinical data sets including genomic data.
• Confident, self-starter capable of taking ownership of tasks with strong attention to detail.
• Excellent organizational, planning, and cross-functional collaboration skills.
• Outstanding verbal and written communication skills.
• Proficient in the MS Office suite.

Nice to Have

• Experience working at or with a Clinical Research Organization (CRO), lab vendor, or biopharmaceutical company.
• International study experience and GDPR implementation.

Technical Stack

• MS Office suite

Team & Environment

You will report to the Director of Clinical Operations and work with a cross-functional project team including clinical laboratory, bioinformatics, regulatory, medical affairs, and operations support.

Benefits & Compensation

• Salary: $150,000 - $170,000 annually + eligibility for equity offerings.
• Paid vacation, sick time, and parental leave.
• Medical, dental, vision, life, and disability coverage.
• Flexible spending accounts.
• 401k with company match.
• Bonus and equity offerings.
• Professional development and upward mobility for high performers.

Work Mode

This role offers a hybrid work model. Locations include remote work or our office in Boulder, CO.

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.