<p>The Senior Clinical Trial Manager (Sr. CTM), in collaboration with the clinical operations program leader, will define local clinical operations strategy and be responsible for country and global execution of complex clinical trials end-to-end consistent with the clinical plan. The Sr. CTM will be responsible for partnering with internal and external business functions and vendors throughout the life cycle of one or more clinical study(ies)in accordance with company SOPs, ICH/GCP, and all applicable local regulations. Candidates for this role must champion a culture of quality and continuous process improvement.</p> <p>Primary Responsibilities</p> <ul> <li>Manage and lead the day-to-day operations of assigned study(ies) to ensure completion per established program goals. </li><li>Effectively manage study timelines, budget, and deliverables so milestones are met on time and within budgeted forecast. </li><li>Support and own the establishment of the clinical trial budget and coordinate with CRO(s) and finance colleagues to forecast and track the financial status of the program against approved budget. </li><li>Manage and lead cross-functional teams and ensure vendors (e.g., CROs, labs, etc.,) are compliant with the contracted scope of work and budget. </li><li>Lead contract research organization (CRO) and vendor selection, and where applicable manage all interactions and deliverables from relevant CROs. </li><li>Perform ongoing vendor management and oversight during the study, including review of performed work against budget, negotiation of scope of work, budget amendments, performance management and issue resolution in close collaboration with the Head of Clinical Operations and Project and Portfolio organization. </li><li>Review and contribute to operational plans including risk-based approaches to site monitoring, fit for purpose strategies for patient recruitment and retention, patient diversification targets, vendor and site reporting requirements, risk identification and mitigation strategies, trial budgets, site selection, and clinical supplies management. </li><li>Ensure inspection readiness at all times. </li><li>Author, audit and/or edit documents, relevant training materials and presentations necessary for study initiation and execution; ensure other documents and manuals (pharmacy, laboratory, and operations manuals/plans) are sufficiently clear and available for study initiation and execution. </li><li>Ensure appropriate reporting, documentation, completion, and finalization of any corrective and preventive action plans resulting from audits and inspections. </li><li>If required coordinate/provide input to Regulatory Affairs for responses to study questions or issues from Health Authorities. </li><li>Coordinate responses to study related questions or issues from IRBs/IECs. </li><li>Accountable for the overall integrity of the TMF for each respective trial. </li><li>Ensure study adherence to ICH/GCP/FDA regulations and SOPs. </li><li>Other clinical operation activities that are delegated by Clinical Operations Leadership. </li></ul> <p>Required Skills & Qualifications</p> <ul> <li>BA/BS degree with 5 plus years clinical trial management experience required. Advanced degree preferred. </li><li>Strong knowledge of ICH/GCP/FDA regulations site monitoring/CRA experience is required. </li><li>Must have global clinical / registrational trial experience, working with vendors and/or CROs, and planning operational activities. </li><li>Experienced working on rare disease trials -Gene & Cell Therapy experience a plus. </li><li>Proven clinical study management skills, and experience across operational aspects of all stages of clinical studies, including the global clinical trials. </li><li>Strong project management and leadership skills; Excellent organizational and time management skills with attention to detail; Effective communication and interpersonal skills; Problem-solving ability and a proactive mindset; High degree of professionalism and integrity. Experience with Veeva eTMF, SharePoint, Word, Medidata RAVE or other EDC systems preferred. </li><li>Must be proficient in spreadsheet development (e.g. Excel) for overseeing clinical trial operations, to generate clinical trial insights/metrics and budget management. </li><li>Must be willing to travel to New York City office and to clinical trial sites as required (~10%). </li></ul> <p>LEXEO Therapeutics is a New York City-based, clinical-stage gene therapy company focused on addressing some of the most devastating genetically defined cardiovascular and central nervous system diseases affecting both larger-rare and prevalent patient populations. LEXEO's foundational science stems from partnerships and exclusive licenses with leading academic laboratories at Weill Cornell Medicine and the University of California, San Diego. LEXEO is advancing a deep and diverse pipeline of AAV-based gene therapy candidates in rare cardiovascular diseases and APOE4-associated Alzheimer's disease and is led by pioneers and experts with decades of collective experience in genetic medicines, rare disease drug development, manufacturing, and commercialization.</p> <p>Lexeo Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.</p>