Lexeo Therapeutics · 16 hours ago
Senior Clinical Trial Associate
New York, NY
Full-time
Hybrid
Mid, Senior Level
$112K/yr - $124K/yr
4+ years expLexeo 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 Senior Clinical Trial Associate (SCTA) is responsible for supporting and overseeing the management of the day-to-day operational activities of the clinical study, ensuring successful execution of clinical programs in accordance with quality standards.
BiotechnologyLife ScienceTherapeutics
Responsibilities
Support the study team with the day-to-day clinical operations of assigned study(ies) to ensure completion per established program goals and standards
Participate in cross-functional study teams, liaise with other functional areas (finance, biosample management, clinical science, safety, regulatory affairs) to accurately coordinate clinical study activities
Manage the Trial Master File (TMF), ensuring it is complete, accurate, and inspection-ready, including performing quality control (QC) checks
Support ongoing vendor management and oversight during the study, including review of performed work against budget, scope of work, budget amendments, performance management and issue resolution in close collaboration with the Clinical Operations study team leader
Author audit and/or edit documents, relevant training materials and presentations necessary for study initiation and execution; ensure other documents and manuals (vendor oversight, pharmacy, laboratory, audit plan, and operations manuals/plans) are sufficient and available for study initiation and execution prior to First Site Activated
Coordinate study Clinical Trials.gov registration and study updates, collaborating with relevant cross-functional team members such as Clinical Science and Regulatory Affairs
Provide input for vendor selection, requirements, and ongoing vendor management, ensuring clear communication and effective collaboration
Oversee agreements, CTA’s/NDA’s are fully executed and filed. Manage the site payments
Lead feasibility assessment and selection of countries and sites with input from Clinical Science, Clinical Operations, and other relevant cross-functional partners
Implement appropriate systems, standards, and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance
Coordinate clinical study timelines with Project Management and core team to meet critical milestones; escalate issues that may jeopardize budget, timelines, and deliverables
Provide monitoring oversight by reviewing monitoring schedules, metrics, and reports. May oversee or manage clinical documentation and reports
Collaborate with study sites and vendors to ensure timely and appropriate processes for obtaining, and shipping of sample integrity for analysis and data generation
Oversee and resolve any corrective and preventive action plans resulting from audits or inspections, ensuring timely reporting and documentation
If required coordinates/provides input to Regulatory Affairs for responses to study questions or issues from Health Authorities
Coordinates responses to study questions or issues from IRBs/IECs
Accountable for overall TMF in the trial and conduct QC to ensure inspection readiness
Provide regular updates of study progression to CTM, senior clinical operations leaders, program management, and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues
Ensure compliance with ICH GCP guidelines, applicable regulations, and company SOPs
Perform other clinical operation activities delegated by Clinical Operations Leader
Qualification
Required
BA/BS degree in life sciences or equivalent required
Minimum of 4 – 5 years of clinical operations experience, with at least 2 years as in-house CRA within Biotech/Pharma or CRO, or at least 3 yrs as a site monitor/clinical research associate (CRA) or equivalent
In-depth knowledge of ICH/GCP/FDA regulations
Proven clinical study management skills, including experience managing timelines, budgets, and operational aspects of clinical studies. Familiarity with vendor/CRO management, drug supply planning, and operational activities
Proficiency in managing clinical documentation, reporting, and ensuring inspection readiness
Strong written and verbal communication skills demonstrated by ability to present clear instruction/direction
Analytical and problem-solving capabilities with exceptional attention to detail and follow-up
Demonstrated ability to work collaboratively in a cross-functional team environment, maintaining a collegial and cooperative work style
Ability to travel to NY HQ quarterly if not within the local area
Company
Lexeo Therapeutics
LEXEO Therapeutics utilizes gene therapy to treat genetically defined cardiovascular and central nervous system diseases.
11-50 employees
H1B Sponsorship
Lexeo Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2022 (2)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$514MKey Investors
Balyasny Asset ManagementSarepta Therapeutics
2025-10-16Post Ipo Equity· $154M
2025-05-27Post Ipo Equity· $80M
2024-03-11Post Ipo Equity· $95M
Leadership Team
R. Nolan Townsend
Chief Executive Officer
Louis Tamayo
Chief Financial Officer
Recent News
BioWorld Financial Watch
2026-01-16
2026-01-13
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