Senior Clinical Trial Associate

Role Summary

The Senior Clinical Trial Associate (SCTA) is a key position within LEXEO. Working closely with the Clinical Operations study lead (e.g. Director/Sr Director), the SCTA is responsible for supporting and overseeing the management of the day-to-day operational activities of the clinical study. The SCTA provides support to ensure successful execution of LEXEO's clinical programs i.e. clinical trial activities and deliverables meet study and program objectives by partnering with internal and external business functions/vendors through the entire life cycle of the study (Plan/ Prepare, Initiate, Execution Close out), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.

Primary 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

Required Skills and Qualifications

• 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…