Clinical Monitoring Operations Manager

📋 Description

• Understand study protocols and essential documents (CMP, ICFs, eCRFs).
• Coordinate Site Selection, Site Initiation, and Close-Out Visits with trial teams.
• Serve as primary contact for interim analyses, database locks, and milestones.
• Lead the monitoring strategy from study start-up through close-out.
• Ensure monitoring deliverables progress on time, within scope and budget.
• Oversee design and maintenance of documents (CMP, eCRFs, SOPs, WIs).

🎯 Requirements

• Bachelor’s degree in business, life sciences, or related field.
• 5-7 years in clinical research, project management, and monitoring operations; PMP preferred.
• Minimum 4 years managing clinical projects across full trial lifecycle.
• Deep knowledge of ICH-GCP, FDA, and global regulatory standards.
• Proficiency in EDC, TMF, CTMS, and IRT systems.
• Advanced proficiency with Microsoft Office; Office 365 and SharePoint.
• Strong communication, leadership, and organizational skills.
• Experience in global, cross-functional environments; multilingual a plus.

🎁 Benefits

• Global CRO with focus on quality and career development.
• Client-facing role with independent, high-trust environment.
• Training and professional development opportunities.
• Equal opportunity employer; diverse, inclusive culture.
• Collaborative teams across Americas, Europe, and Asia-Pacific.