Senior Clinical Trial Lead - COPD & Late-Stage Ops

Generate Biomedicines; United States; On-site; USD 140,000 - 196,000; Full time

Job summary

Generate Biomedicines is seeking a Senior Clinical Trial Manager to lead late-stage COPD trial operations. You will oversee CROs, central labs, sites, and vendors, ensuring timelines, data flow, and quality across study milestones.

You’ll mentor junior staff and collaborate with QA to maintain inspection readiness. The role reports to the Director, Clinical Operations and requires strong communication skills, meticulous planning, and the ability to travel up to 30% domestically and

Qualifications

• Bachelor's degree required; advanced scientific degree preferred.
• 8+ years of experience in clinical operations, with 4+ years in late-stage trial operations.

Responsibilities

• Independently manages operational aspects of late-stage COPD-related trials (vendors, sites, CROs).
• Leads cross-functional study team meetings and delivers milestones.
• Manages start-up, enrollment, monitoring, data flow, and timelines across sites and vendors.
• Develops and reviews study documents and recruitment materials.
• Maintains TMF and ensures GCP compliance and inspection readiness.

Skills

Clinical Trial Management

Vendor Oversight

Budget Management

Team Mentoring

Regulatory Knowledge

Education

Bachelor's degree

Advanced degree preferred

Job description

Generate Biomedicines is seeking a Senior Clinical Trial Manager to lead late-stage COPD trial operations. You will oversee CROs, central labs, sites, and vendors, ensuring timelines, data flow, and quality across study milestones.

You’ll mentor junior staff and collaborate with QA to maintain inspection readiness. The role reports to the Director, Clinical Operations and requires strong communication skills, meticulous planning, and the ability to travel up to 30% domestically and