Senior Clinical Trial Manager

Responsibilities

• Independently manage operational aspects of late-stage trials, including CROs, central labs and sites
• Lead cross-functional study team meetings and deliverables
• Identify, qualify and select clinical trial sites and investigators
• Supervise day-to-day trial execution, enrollment, monitoring and compliance
• Manage clinical study budgets and execution timelines
• Lead monitoring oversight visits and vendor collaboration
• Maintain the Trial Master File and prepare for inspections
• Mentor and train junior staff

Requirements

• Bachelor's degree required
• 8+ years in clinical operations, including 4+ years in late-stage sponsor trials
• Experience with CRO, vendor and laboratory oversight
• Detailed knowledge of GCP
• Strong organizational and communication skills
• Travel up to 30%

Preferred Qualifications

• Advanced scientific degree
• Respiratory therapeutic area experience
• Knowledge of FDA, EMA and MHRA requirements

About the Company

Generate Biomedicines is a clinical-stage generative biology company using machine learning to design protein-based medicines.