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Role Summary:
- Defines the clinical operations strategy and be responsible for country and global execution of complex clinical trials
- Partners with internal and external business functions and vendors
- Champions a culture of quality and continuous process improvement
Primary Responsibilities:
- Manages day-to-day operations of assigned study to ensure completion per established program goals
- Establish the clinical trial budget and collaborate with CRO(s) and finance colleagues to forecast and track the financial status of the program against approved budget
- Ensures rigor and availability of documentation to demonstrate sufficiency of sponsor oversight
Required Skills and Qualifications:
- Advanced degree in life sciences preferred with a minimum of 6 years clinical trial management experience
- Strong knowledge of ICH/GCP/FDA regulations, site monitoring/CRA experience is required
- Analytical and problem-solving capabilities
Lexeo Therapeutics
Lexeo Therapeutics is a clinical-stage genetic medicine company headquartered in New York City, pioneering cardiac genetic medicine candidates to treat the root causes of inherited cardiovascular diseases. The company's work culture is a hybrid model with 2 days/week in the New York City office and 3 days working from home.