Job Description

The Clinical Trial Manager (CTM) or Senior Clinical Trial Manager (Sr. CTM) leads the execution of global clinical studies from startup through close-out. The CTM/Sr. CTM partners closely with cross-functional teams and external vendors to deliver high-quality clinical trials on time and within budget while ensuring compliance with regulatory standards. The CTM will independently manage study execution, while the Sr. CTM will lead more complex programs with broader strategic and cross-functional responsibilities.

Primary Responsibilities

Clinical Trial Execution

• Lead day-to-day management of clinical studies to ensure delivery against timelines, budget, and quality expectations
• Drive study milestones and proactively identify and mitigate risks

Vendor & CRO Management

• Oversee CROs, laboratories, and vendors to ensure performance aligns with scope, timelines, and budget
• Manage vendor relationships, including scope changes, issue resolution, and ongoing performance oversight

Cross-Functional Collaboration

• Partner with internal stakeholders across Clinical, Regulatory, Data Management, and other functions
• Serve as a central operational lead to ensure alignment and efficient study execution

Study Planning & Strategy

• Contribute to study planning, including timelines, resource plans, budgets, and risk management strategies
• Provide operational input into protocol development, feasibility, and study design

Site & Study Oversight

• Act as the primary sponsor contact for study sites
• Oversee site startup and ongoing site management activities
• Ensure proper sample handling, data flow, and protocol adherence

Quality & Compliance

• Ensure compliance with ICH/GCP, FDA regulations, and company SOPs
• Maintain inspection readiness and support audits and regulatory inspections
• Ensure completeness and integrity of the Trial Master File (TMF)

Documentation & Communication

• Author and review study plans, operational documents, and training materials
• Communicate study status, risks, and mitigation plans to stakeholders

Continuous Improvement

• Contribute to process improvements and operational excellence initiatives
• (Sr. CTM) Lead cross-study or departmental initiatives

Required Skills and Qualifications

• Bachelor’s degree in life sciences or a related field; advanced degree preferred
• Clinical Trial Manager: minimum 7 years of clinical research experience; 4 years with advanced degree
• Senior Clinical Trial Manager: experience leading complex or global studies, worked on a clinical study from concept to database lock
• Strong knowledge of ICH/GCP, FDA regulations, and clinical trial operations
• Experience managing CROs and other external vendors
• Proven ability to manage timelines, budgets, and multiple priorities
• Excellent communication, problem-solving, and leadership skills
• Demonstrated leadership skills
• Ability to work effectively in a fast-paced, collaborative environment
• Ability to travel to sites as needed, including international travel
• Ability to work Eastern Time Zone and travel to New York HQ quarterly

About Lexeo

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. Our lead program, LX2006, targets cardiomyopathy associated with Friedreich’s Ataxia and anchors a broader pipeline addressing genetically defined conditions such as hypertrophic and arrhythmogenic cardiomyopathies. Backed by a strong financial foundation, Lexeo is positioned to translate groundbreaking science into durable clinical impact.

Our work culture is a hybrid model with 2 days/week in the New York City office and 3 days working from home.

Lexeo Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.