Clinical Monitoring Operations Manager

📋 Description

• Understand study protocols and essential documents: CMP, ICFs, eCRFs.
• Coordinate Site Selection Visits, Site Initiation Visits and Close-Out Visits.
• Serve as primary contact for interim analyses, database locks, milestones.
• Lead the monitoring strategy from study start-up through close-out.
• Ensure monitoring deliverables are on time, within scope and budget.
• Oversee document design and maintenance (CMP, eCRFs, site letters, SOPs, WI’s).

🎯 Requirements

• Bachelor’s degree in business, life sciences, or related field.
• 5-7 years in clinical research, project management & monitoring ops; PMP preferred.
• Minimum 4 years managing clinical projects across full trial lifecycle.
• Deep knowledge of ICH-GCP, FDA, and global regulatory standards.
• Analytical skills with monitoring data, KPIs, and reporting.
• Experience in global, cross-functional environments; multilingual a plus.