Clinical Operations Manager

About the role
We are seeking a proactive, experienced Clinical Researcher to spearhead clinical operations at Cleancard! You will own the clinical and regulatory pillar of the business, including IRB applications, clinical studies and analysis, grant funding, QMS, and planning/execution for FDA processes. You will manage relationships with clinical partners, bringing them together with our cross-disciplinary team of scientists and engineers to deliver on the clinical studies that demonstrate the potential of our non-invasive cancer diagnostic. You will be an integral member of our tight knit team and involved in the overall development of our product and company! As we progress through the development lifecycle, a key challenge in this role will be integrating the different elements (including biochemical, hardware, and software) into a compliant, easy-to-use, and easy-to-manufacture product. Your ownership of our clinical and patient relationships will also be the starting point for our future sales network. This role is based in our San Francisco HQ.

Even if you feel like you don’t meet all of the qualifications, we encourage you to apply!
Research shows that while men apply to jobs where they meet an average of 60% of the criteria, women and other underrepresented people tend to only apply when they meet 100% of the qualifications. At Cleancard, we welcome diverse perspectives and people who think rigorously and aren’t afraid to challenge the status quo. Cleancard is an equal opportunity employer; we celebrate diversity and are committed to creating an inclusive environment, free from discrimination or harassment, for all employees.

Key Responsibilities

• Manage clinical studies, to include overall design with cohort and sample selection, as well as communication with sites.
• Perform robust data analysis on clinical data and manage the experimental plan.
• Plan and manage eventual FDA submission, to include setting up QMS systems and ensuring ISO compliance.
• Manage IRB applications and study design documentation.
• Identify and execute grant funding opportunities.

Qualifications:

• Grad-level degree in a relevant field (e.g. MD or MS/PhD within clinical research) is preferred.
• Demonstrated experience in clinical study design from initial concept to execution.
• Strong knowledge of FDA requirements and pathways for clinical diagnostics.
• Experience with implementing QMS systems for a clinical diagnostic is highly desirable.
• Previous startup experience preferred.
• Proactive and able to independently manage tasks to meet deadlines.
• Excellent attention to detail and strong written and verbal communication skills.
• Ability to successfully participate in a fast-paced, highly creative and enthusiastic, start-up environment with people who are motivated to succeed together as a team.

Why Join Us:

• Be part of a visionary team working on important research in non-invasive cancer diagnostics.
• Work in a collaborative and innovative environment with leading experts across various fields.
• Competitive salary and benefits package.
• Opportunities for professional growth and development in a fast-paced startup setting.
• Make a tangible impact on healthcare and improve patient outcomes through at-home diagnostics.