About Quantgene:

As a new technology leader in the field of early cancer detection, Quantgene is launching a product poised to change the course of medicine: a multi-cancer screening test capable of detecting the ten deadliest cancers in the blood at the earliest possible stage. Our clinical network includes many of the best and largest clinical institutions in the US and Europe. Global leaders in science, oncology, and biotech have validated our research and methodologies. Quantgene's machine learning team is world-class, and our wet lab division is led by one of the most accomplished teams in genomic diagnostics.

We are small, agile and highly effective. We have a team of 25, and we are growing fast.

Job Description:

Quantgene is looking for an organized, hard-working, and self-motivated full-time Clinical Trial Manager to join our Clinical team in Santa Monica. The Clinical Trial Manager will support successful design and day-to- day execution of clinical trials from concept through publication. You will work closely with the Chief Medical Officer, clinical, and executive teams to ensure the highest regulatory standards are kept. Key accountabilities include successful conduct of clinical studies consistent with applicable regulations, guidelines and procedures, as well as managing clinical project timelines, budgets, deliverables, and overall communications.

The ideal candidate will have deep experience managing clinical trials for blood-based tests. 

Responsibilities:

• Manage all aspects of assigned clinical studies including but not limited to: PI selection, study startup, authoring/preparation of study-related documentation, study conduct and close out
• Create new protocols, case report forms, consent documents, laboratory and study procedures manuals, and ensure the highest quality of regulatory compliance
• Manage the existing clinical team and provide leadership through a systematic approach
• Provide regular updates of study progression to the CEO and Chief Medical Officer
• When there are issues (and there always will be), proactively identify and resolve them
• Create metrics, targets, and reports to provide to C-suite. Ensure targets are being met
• Work on study feasibility and selection of sites for study conduct (both in North America and Europe)
• Assure compliance with ALL regulatory requirements by monitoring compliance with all company standard operating procedures (SOPs), GCP, FDA and applicable international regulations concerning clinical activities (Europe and USA)
• Assist with the smooth transition of clinical data to the data science team to ensure successful integration into the Quantgene Software Platform

Requirements:

• BS degree (or higher) with 3+ years’ of clinical trial management and industry experience (biotech, pharma or device - ideally blood based)
• Deep experience in the management of CROs and other vendors
• Must be confident in clinical protocol development, clinical study design, study planning and management, and site monitoring
• Full understanding of GCP, ICH guidelines and other US and European clinical regulatory requirements
• Project Management and team leadership
• Excellent computer skills in excel and other EDC’s like ClinCapture
• Industry experience with oncology, or blood-based trials (ideally)

Location, Perks, Compensation, and Timeline

Compensation is competitive, including substantial stock options that move the needle. We offer unlimited vacation, 401k matching, and medical/dental insurance. We are in the Arts & Tech district in Santa Monica, CA in modern, bright, and spacious converted industrial barn with a full kitchen…all within walking distance to the Metro. Some work-from-home and flex days are available.

Must live in the Los Angeles area and be willing to commute to our office. Relocation is possible for the right person. We are looking to hire before August 1st.

Culture

Quantgene values entrepreneurial thinkers who love to devise new ideas and drive them to fruition. Your voice will be heard here, and welcome. Our office is a fun, collaborative environment with smart people who are passionate about wellness, changing healthcare, and saving lives through early cancer detection. It’s fun, challenging, and ultimately meaningful work that makes a genuine difference.

Job Type: Full Time

Additional Information:

All your information will be kept confidential according to EEO guidelines.

Quantgene is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.