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 regulatory compliance
• Coordinate patient referral and enrollment processes across multiple sites to drive efficiency and accuracy
• Manage vendor relationships and CRO performance, addressing issues 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
• Experience in rare disease or complex therapeutic areas preferred
• Strong understanding of site start-up processes, vendor management, and CRO oversight
• Ability to drive urgency and manage multiple priorities in a fast-paced environment
• Bachelor's degree preferred but not required; open to CRA or CTM backgrounds