Senior Clinical Trial Manager - COPD/Respiratory, Late-Stage

Regulatory Jobs; Somerville (MA); On-site; USD 140,000 - 196,000; Full time

Job summary

Generate Biomedicines seeks a Senior Clinical Trial Manager to lead late-stage COPD/ asthma trial execution. You will manage CROs, central labs, and sites, ensuring startup, enrollment, monitoring, data flow, and timelines align with program goals.

You will supervise cross-functional teams, develop study documents, and oversee budgets while mentoring junior staff. Travel up to 30% domestically and internationally is expected.

Qualifications

• Bachelor’s degree required; advanced scientific degree preferred.
• 8+ years of experience in clinical operations.
• Experience in late stage trial operations with a sponsor company.
• Experience in CRO, vendor and laboratory oversight is required.
• Able to travel up to 30% domestically and internationally.

Responsibilities

• Manage operational aspects of clinical trials with CROs, central labs, and sites for late-stage asthma/COPD studies.
• Lead cross-functional study team meetings and deliverables.
• Identify, qualify, and select sites and investigators with CROs; manage key relationships.
• Oversee day-to-day trial execution: startup, enrollment, monitoring, data flow metrics.
• Facilitate investigator meetings, kickoffs, monitoring training, and vendor meetings.
• Develop and review study documents (ICFs, guidelines, manuals, training materials).
• Contribute to protocol amendments, CRFs, IRB/Ethics applications, recruitment materials.
• Manage budgets and execution timelines; ensure adherence to goals.
• Lead monitoring oversight visits and collaboration with CROs, investigators, site staff.
• Review study reports for timely data collection; promote SPA tools and SOPs.
• Create action plans addressing protocol compliance, safety, data, and admin issues.
• Maintain TMF and ensure inspection readiness with QA and regulatory compliance.
• Prepare trial data presentations for management, scientific meetings, and advisory boards.
• Train and mentor junior staff.

Skills

Communication skills

Public speaking

Mentor junior staff

Organizational skills

Interpersonal skills

Attention to detail

Team collaboration

Travel readiness

Education

Bachelor’s degree

Advanced degree preferred

Job description

Generate Biomedicines seeks a Senior Clinical Trial Manager to lead late-stage COPD/ asthma trial execution. You will manage CROs, central labs, and sites, ensuring startup, enrollment, monitoring, data flow, and timelines align with program goals.

You will supervise cross-functional teams, develop study documents, and oversee budgets while mentoring junior staff. Travel up to 30% domestically and internationally is expected.