Senior Study Start-Up Manager

📋 Description

• Senior clinical operations role driving start-up from site identification to activation and ongoing
• Ensure trials launch efficiently, on schedule, and compliant with ICH/GCP, regulations, and
• Span the Americas (US, Canada, Latin America) and influence cross-functional processes, workflows
• Provide leadership, mentoring, and resource planning; collaborate with clinical and external
• Directly manage onboarding, coaching, and development of team members; oversee external

🎯 Requirements

• Bachelor’s degree or higher in a scientific or healthcare discipline preferred.
• 7+ years of progressive experience in clinical research/clinical operations in biotech/pharma/CRO.
• Strong expertise in study start-up activities: site feasibility/selection, documentation
• Thorough understanding of ICH/GCP, country-specific regulations, and clinical trial SOPs.
• Experience with Functional Service Provider models and external vendor collaboration.
• Previous line management experience including hiring, onboarding, training, mentoring, and

🎁 Benefits

• Base salary of $136,400–$181,400 annually, commensurate with experience and location.
• Eligible for annual bonus plan and discretionary equity; Employee Stock Purchase Plan.
• Medical, dental, vision insurance; 401(k) with employer matching; FSA/HSA options.
• Life insurance, paid time off, wellness programs; remote work opportunity within the United States.
• Opportunity to contribute to international clinical development programs with patient impact.
• Collaborative environment focused on professional development and continuous improvement.