Senior Director, Clinical Systems

📋 Description

• Own the operational development and ongoing business management of Amylyx’s Clinical Systems
• Lead the operational implementation and ongoing optimization of a Clinical Trial Management System
• Establish effective operational system governance, standards, business processes, roles, and
• In conjunction with Information Delivery, identify and evaluate opportunities to leverage
• Partner with Clinical Compliance and Records to ensure clinical systems and associated processes
• Partner closely with IT, Quality, Clinical Business Operations, and other stakeholders to evaluate

🎯 Requirements

• Bachelor’s degree in life sciences, information systems, technology, business, or a related
• Typically 15+ years of progressive experience in Clinical Operations, Clinical process development
• Demonstrated expertise with clinical platforms, including experience leading system implementations
• Prior experience leading and managing CTMS and other clinical platform implementations is required.
• Knowledge of applicable clinical trial process, regulatory and quality requirements, including
• Strong project and change management capabilities, including the ability to manage multiple complex