Backed by Sequoia.
About the role
The Senior Clinical Trial Manager is a key contributor to MyOme’s clinical evidence generation strategy with responsibility for executing assigned clinical studies within agreed upon timelines and budgets. This is a highly cross-functional role that partners closely with internal stakeholders and external partners to translate evidence needs into actionable clinical protocols and oversees their execution by CROs, supporting vendors, and study sites.
What they're looking for
- Own study execution within agreed upon timelines and budget, ensuring compliance with Good Clinical Practice, applicable regulatory requirements, study protocols and MyOme SOPs
- Leads the execution of studies from feasibility to delivery of analysis-ready datasets
- Leads the identification and selection process for CROs and other vendors supporting study execution
- Primary point of contact for vendors involved in study execution
- Oversees study budgets, reviewing and approving vendor invoices, tracking spend versus plan in partnership with Accounting and Finance
- Contributes to the development of study-related documents including protocols, informed consent forms, laboratory manuals, monitoring plans, communication plans, training materials and SOPs
More about this role
MyOme’s mission is to provide clinically actionable genetic information to patients throughout their lives. We combine clinical-grade whole genome sequencing, advanced AI methods for genome interpretation, and seamless digital tools for doctors and patients to order and access results. Our team is composed of seasoned entrepreneurs, scientists, and operators, and we're backed by top-tier investors.
The Senior Clinical Trial Manager is a key contributor to MyOme’s clinical evidence generation strategy with responsibility for executing assigned clinical studies within agreed upon timelines and budgets. This is a highly cross-functional role that partners closely with internal stakeholders and external partners to translate evidence needs into actionable clinical protocols and oversees their execution by CROs, supporting vendors, and study sites. You must have substantial experience successfully managing clinical studies through CROs.
- Own study execution within agreed upon timelines and budget, ensuring compliance with Good Clinical Practice, applicable regulatory requirements, study protocols and MyOme SOPs.
- Leads the execution of studies from feasibility to delivery of...
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