Clinical Trial Manager/Senior Clinical Trial Manager

Clinical Trial ManagerThe 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 ResponsibilitiesLead day-to-day management of clinical studies to ensure delivery against timelines, budget, and quality expectationsDrive study milestones and proactively identify and mitigate risksOversee CROs, laboratories, and vendors to ensure performance aligns with scope, timelines, and budgetManage vendor relationships, including scope changes, issue resolution, and ongoing performance oversightPartner with internal stakeholders across Clinical, Regulatory, Data Management, and other functionsServe as a central operational lead to ensure alignment and efficient study executionContribute to study planning, including timelines, resource plans, budgets, and risk management strategiesProvide operational input into protocol development, feasibility, and study designAct as the primary sponsor contact for study sitesOversee site startup and ongoing site management activitiesEnsure proper sample handling, data flow, and protocol adherenceEnsure compliance with ICH/GCP, FDA regulations, and company SOPsMaintain inspection readiness and support audits and regulatory inspectionsEnsure completeness and integrity of the Trial Master File (TMF)Author and review study plans, operational documents, and training materialsCommunicate study status, risks, and mitigation plans to stakeholdersContribute to process improvements and operational excellence initiatives(Sr. CTM) Lead cross-study or departmental initiativesRequired Skills and QualificationsBachelor's degree in life sciences or a related field; advanced degree preferredClinical Trial Manager: minimum 7 years of clinical research experience; 4 years with advanced degreeSenior Clinical Trial Manager: experience leading complex or global studies, worked on a clinical study from concept to database lockStrong knowledge of ICH/GCP, FDA regulations, and clinical trial operationsExperience managing CROs and other external vendorsProven ability to manage timelines, budgets, and multiple prioritiesExcellent communication, problem-solving, and leadership skillsDemonstrated leadership skillsAbility to work effectively in a fast-paced, collaborative environmentAbility to travel to sites as needed, including international travelAbility to work Eastern Time Zone and travel to New York HQ quarterly$143,350 - $180,000 a year Compensation is dependent on qualifications and experienceAbout LexeoLexeo 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.