Clinical Trial Manager

Role Summary
The Clinical Trial Manager (CTM) will be responsible for the end-to-end execution of complex Clinical Trials consistent with the clinical plan. The CTM will be responsible for partnering with internal and external business functions and vendors throughout the study’s life cycle 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. 
Location
Our work culture is a hybrid model with days in the New York City office and days working from home. A remote working model may be considered for exceptional candidates.
Primary Responsibilities

• Manage and drive the day-to-day operations, contribute to development and execution of study timelines, and vendor deliverables of assigned study to ensure completion per established program goals; managing risks and quality as well as escalating issues that may jeopardize time, cost, and quality of deliverables.
• Perform ongoing vendor management and oversight during the study, including review of performed work against budget, negotiation of scope of work, Change orders and budget amendments, performance management and issue resolution in close collaboration with the Clinical Operations program leader.
• Coordinate with CRO and Lexeo finance to track the financial status against approved budget to include invoice review and forecasting.
• Drive feasibility assessment i.e., selection of countries and sites with input from Clinical Program Leader and other relevant cross-functional partners.
• Manage site start-up and patient forecasting, contribute to database design (CRFs). ICFs, patient diaries, essential documents etc.
• Prepare vendor requirements, defining project scope and selection of vendors, effectively managing interactions with relevant cross-functional partners and vendor teams. 
• Ensure rigor and availability of Vendor Oversight Plan and of documentation to demonstrate sufficiency of sponsor oversight.
• Author audit and/or edit documents, relevant training materials and presentations necessary for study initiation and execution; 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. 
• Author audit and/or edit Charters for Data Safety Monitoring Committee (DSMC)
• Work closely with study sites/vendors to ensure timely and appropriate processes for obtaining, and shipping to ensure bio- sample integrity for analysis and data generation.
• Ensure and communicate with the CRO and other relevant vendors to ensure data health, and root cause and remediation of deviations i.e., cleaned and coded appropriately to meet milestones and submission activities.
• Ensures appropriate reporting, documentation, completion, and finalization of any corrective and preventive action plans resulting from site audits and inspections.
• Coordinates responses to study questions or issues from IRBs/IECs
• Accountable for overall TMF in the trial always ensuring inspection readiness.
• Ensures study adherence to ICH/GCP/FDA regulations and SOPs.
• Other clinical operation activities delegated by Clinical Program Leader

Required Skills & Qualifications

• Minimum of BA/BS degree in a scientific filed or other comparable degree or scientific education, with 4 years direct and independent Clinical Trial management inclusive of development of timelines, budget, CRO selection within pharma/biotech or 6 yrs. within a CRO with at least 2 years of global study experience
• Willing and able to travel ~25% both domestically and internationally
• Gene Therapy and rare disease experience are highly desirable
• Strong knowledge of ICH/GCP/FDA regulations, with at least 2 years of Site monitoring/CRA experience required
• Proven clinical study management skills, and experience of the operational aspects of all stages of clinical studies inclusive of development of timelines and budgets. Preferably working in a global environment, collaborating with vendors and/or CROs, drug supply management and planning operational activities
• Well-developed written and verbal communication skills demonstrated by ability to present clear instruction/direction.
• Analytical and problem-solving capabilities
• Collaborative and collegial work style and cultural fit
• Diligence and follow-up

Anticipated Salary
Depending on qualifications and overall experience, base salary is likely to be $115,000 - $155,000 per year.
Lexeo Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.
 

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