Project Oversight

• Overall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines.
• Monitoring support visits (Co-monitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above.
• May support clinical project team by providing oversight of study deliverables related to other departments (e.g. Data Management, TMF Operations, etc.)
• Oversee regional startup and feasibility activities.
• Assist in vendor management activities as required per project.
• Perform review of visit reports for quality, compliance and appropriate site management.
• Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan.
• Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on progress.
• Contribute to financial project management processes as applicable. May include but may not be limited to input on revenue recognition, site payments, and site pass-through expense review.
• May be required to manage/oversee investigator sites including CRA responsibilities, on a temporary or permanent basis.

Project Liaison

• Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls
• Attend meetings with Study Sponsor to provide status updates on country and site progress
• Provide operational support and guidance to the monitoring team throughout project.