Clinical Trial Manager

Job Summary

A company is looking for a Clinical Trial Manager (CTM) to support the operational execution of a complex rare disease Phase 3 gene therapy trial.

Key Responsibilities

• Oversee site start-up activities for U.S. and global sites, ensuring timely activation and compliance with regulatory requirements
• Coordinate patient referral and enrollment processes across multiple sites, driving efficiency and accuracy
• Manage vendor relationships and CRO performance, escalating issues and removing barriers to maintain timelines

Required Qualifications

• Minimum of 5 years of experience in clinical operations or trial management, with recent hands-on involvement in clinical studies within the last two years
• Experience in rare disease or complex therapeutic areas preferred due to endpoint and execution complexity
• Strong understanding of site start-up processes, vendor management, and CRO oversight
• Ability to drive urgency, maintain diligence, and manage multiple priorities in a fast-paced environment
• Open to candidates with CRA or CTM backgrounds; bachelor's degree preferred but not required