Senior Clinical Trial Manager, Cambridge, MA

Isomorphic Labs seeks a Senior Clinical Trial Manager to lead cross-functional teams through all phases of the clinical trial lifecycle, from start-up through close-out. The role requires managing trial operations to ICH/GCP standards, overseeing vendor and site relationships, and collaborating with the Head of Clinical Operations as the clinical department expands.

Responsibilities

• Lead cross-functional teams through complete clinical trial lifecycle management
• Oversee study start-up, maintenance, and close-out activities to regulatory standards
• Manage vendor contracts, change orders, and cost tracking for clinical trials
• Contribute to development of regulatory documents including protocols and clinical summaries
• Develop training materials and trial-specific documentation for sites and staff

Requirements

• Experience executing clinical trial start-up, conduct, and close-out activities
• Proficiency with ICH/GCP Guidelines and regulatory standards
• Demonstrated ability to manage cross-functional teams and build vendor relationships
• Strategic thinking with strong problem-solving and adaptability skills
• Experience managing change orders, contracts, and vendor invoicing