Key Facts

Remote From:

Full time

Senior (5-10 years)

English

Hard Skills

Web Administration Clinical Trial Management Systems Vendor Management Budget Management Training Documentation Protocol Oriented Programming Safety Audits Clinical Data Exchange Feasibility Studies Scope Management +9 more

Other Skills

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Program Management
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Communication
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Leadership
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Time Management
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Teamwork
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Problem Solving

Roles & Responsibilities

Bachelor's degree in life sciences or a related field; advanced degree preferred.
Clinical Trial Manager: minimum 7 years of clinical research experience; at least 4 years with advanced degree; or equivalent leadership experience for Sr. CTM.
Experience leading complex or global studies from concept to database lock; strong knowledge of ICH/GCP, FDA regulations, and CRO/vendor management.
Proven ability to manage timelines, budgets, and multiple priorities; excellent communication and leadership skills; ability to travel and work across time zones (Eastern Time Zone) and to New York HQ quarterly.

Requirements:

Lead day-to-day management of global clinical trials to meet timelines, budget, and quality expectations; proactively identify and mitigate risks.
Oversee CROs, laboratories, and external vendors; manage relationships, scope changes, issue resolution, and performance to ensure alignment with scope, timelines, and budget.
Partner with internal stakeholders across Clinical, Regulatory, Data Management, and other functions; serve as the central operational lead to ensure alignment and efficient study execution; contribute to study planning including timelines, resource plans, budgets, and risk management.
Act as the primary sponsor contact for study sites; oversee site startup and ongoing site management; ensure proper sample handling, data flow, protocol adherence, TMF completeness; ensure compliance with ICH/GCP and FDA regulations, and support audits.

Lexeo Therapeutics

About Lexeo Therapeutics

Based in New York City, Lexeo Therapeutics is a clinical-stage genetic medicines company dedicated to transforming healthcare by applying pioneering science to fundamentally change how disease is treated. Building on groundbreaking research from Weill Cornell Medicine and the University of California San Diego, Lexeo partners with preeminent institutions on the cutting edge of gene therapy research. Using a stepwise development approach, Lexeo is leveraging early proof-of-concept functional and biomarker data to advance a pipeline of cardiovascular and APOE4 associated Alzheimer's disease programs, and is led by pioneers and experts with decades of collective experience in genetic medicines, rare disease drug development, manufacturing and commercialization. For more information, please visit www.lexeotx.com.

Founded: 2018

Company size: 11 - 50

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Job description

Role Summary

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.