Remote Clinical Trial Lead — Operations & Strategy

Cabaletta Bio; All (MO); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive benefits

PTO

Stock option plans

Job summary

Cabaletta Bio is seeking an Associate Director, Clinical Trial Lead, Clinical Operations to provide oversight and guidance to clinical operations vendors and teams. You will plan, execute, data‑manage, and close out assigned studies with emphasis on quality and regulatory compliance.

You will contribute to development planning, protocol and data management strategies, and SOP improvements while mentoring in-house CRAs and coordinating with CROs and sites across global trials.

Qualifications

• BA/BS in a scientific or healthcare-related discipline.
• 8–10+ years of clinical research experience, with global trial management.
• Experience managing CROs and external vendors in a matrix environment.
• Strong knowledge of ICH-GCP, regulatory requirements, and SOPs.
• Leadership of complex studies, budgets, timelines, and resources.
• Cell/Gene therapy or oncology experience preferred.

Responsibilities

• Lead planning, execution, management, and delivery of regional and global clinical trials from protocol development through study conduct, closeout, analysis, and reporting.
• Provide operational leadership for all trial activities including startup, site activation, recruitment, monitoring, and data review.
• Serve as primary liaison among internal teams and external stakeholders (CROs, sites, vendors, regulatory affairs, QA, safety, DM, medical writing).
• Oversee CRO/vendor selection, onboarding, performance, budgets, and contractual obligations.
• Build relationships with investigational sites and monitors to support study execution.
• Develop and approve trial documents and operational plans; manage budgets and forecasts; implement process improvements.
• Apply project management methods and metrics to track progress and risks; drive remote monitoring and optimized supply management.
• Ensure compliance with ICH-GCP and SOPs; manage CAPAs, audits, and inspection readiness.
• Mentor in-house CRAs and contingent staff; support continuous improvement of clinical operations SOPs.

Skills

Leadership

Project management

Communication

Cross-functional teams

Budget management

Education

BA or BS degree in a scientific or healthcare-related discipline

Job description

Cabaletta Bio is seeking an Associate Director, Clinical Trial Lead, Clinical Operations to provide oversight and guidance to clinical operations vendors and teams. You will plan, execute, data‑manage, and close out assigned studies with emphasis on quality and regulatory compliance.

You will contribute to development planning, protocol and data management strategies, and SOP improvements while mentoring in-house CRAs and coordinating with CROs and sites across global trials.