Remote Senior Clinical Trial Manager - Genomics

MyOme; San Francisco (CA); On-site; USD 145,000 - 185,000; Full time

Benefits offered by this job

Healthcare

401K

Unlimited PTO

Professional development

Off-sites & team meals

Leadership access

Job summary

MyOme, a genetic information company, is seeking a Senior Clinical Trial Manager to execute complex clinical studies with CROs and cross-functional partners. You will drive protocols, budgets, and timelines while ensuring regulatory compliance and data quality across multi-site trials.

Ideal candidates have 8+ years in trial management, strong FDA/GCP knowledge, and experience with large IVD studies. Willingness to travel up to 20% is required, with equity opportunities in the US remote role.

Qualifications

• 8+ years of clinical trial management experience, including 5+ years running IVD studies.
• Experience with interventional diagnostic studies and/or cancer early detection studies preferred.
• Experience managing large studies (5,000+ participants) preferred.
• Proven success managing CROs and vendors as primary accountability on large, multi-site studies.
• Strong FDA regulation and Good Clinical Practice knowledge for diagnostic studies.
• Excellent communication, negotiation and stakeholder management skills.
• Willingness to travel up to 20%.

Responsibilities

• Own study execution within timelines and budget, ensuring GCP and regulatory compliance.
• Lead studies from feasibility to delivery of analysis-ready datasets.
• Identify and select CROs and vendors for study execution.
• Serve as primary contact for vendors in study execution.
• Oversee budgets and vendor invoices, track spend vs. plan with Accounting/Finance.
• Develop study documents: protocols, informed consent forms, manuals, monitoring plans, SOPs.
• Lead cross-functional study team and escalate risks to MyOme management.
• Lead cross-functional risk review and manage operational risks.
• Provide updates on study progress across stakeholders.

Skills

Clinical trial management

CRO/vendor management

Stakeholder management

Regulatory compliance (FDA / GCP)

Analytical thinking

Communication

Project budgeting

Travel readiness

Education

Bachelor's degree in life sciences or related field

Advanced degree (MS/MPH/MSN/PharmD/PhD) preferred

Tools

PMP certification

Job description

MyOme, a genetic information company, is seeking a Senior Clinical Trial Manager to execute complex clinical studies with CROs and cross-functional partners. You will drive protocols, budgets, and timelines while ensuring regulatory compliance and data quality across multi-site trials.

Ideal candidates have 8+ years in trial management, strong FDA/GCP knowledge, and experience with large IVD studies. Willingness to travel up to 20% is required, with equity opportunities in the US remote role.