Clinical Operations Lead (Clinical Trial Manager)

Project Oversight:

• Overall oversight of regional CRAs to ensure site compliance with study protocol, ICH-GCP, local regulations, and timelines.
• Conduct monitoring support visits and review visit reports for quality and site management.
• Proactively manage site and country performance, including recruitment and data collection.

Project Liaison:

• Conduct regular global CRA calls and attend sponsor meetings to provide status updates.
• Provide operational support and project training to regional CRAs.
• Serve as first point of contact for study-specific questions and escalate issues as needed.

Study Documents and Plans:

• Develop training materials, study tools, and monitoring plans for sites and CRAs.
• Implement enrollment and recruitment strategies with the clinical project team.
• Prepare presentations for sponsor kickoff meetings, investigator meetings, and site visits.