Sr. Clinical Operations Lead (LATAM)

2 weeks ago Be among the first 25 applicants

Overview shows responsibility for clinical operations of a project at regional / global level, with oversight of project deliverables, CRAs, and Investigator sites in line with the Monitoring Plan, Protocol, GCP, ICH guidelines and local regulations. The COL acts as primary liaison between CRAs and the clinical project team. Additional responsibilities include project-specific training of CRAs, assessment visits with CRAs, implementing enrollment and recruitment strategies, preparing monitoring plans and other documentation, and overseeing monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions. The COL develops study tools for site / CRA use, reviews visit reports, tracks protocol deviations, and supports other clinical operations objectives.

Responsibilities

• Overall oversight of regional CRAs to ensure site compliance with study protocol, study plans, ICH-GCP, local regulations, and study timelines.
• Monitoring support visits (co-monitoring) to aid site / CRA in satisfactory performance and compliance with standards.
• Provide oversight of study deliverables related to other departments (e.g., Data Management, TMF Operations) as required.
• Oversee regional startup and feasibility activities.
• Assist in vendor management activities as required per project.
• Review visit reports for quality, compliance, and site management.
• Ensure compliance with high-quality and timely project deliverables per project requirements and the monitoring plan.
• Proactively manage site and country performance (recruitment, data collection, document collection, TMF review) and inform the clinical project team on progress.
• Contribute to financial project management processes as applicable (e.g., revenue recognition, site payments, site pass-through expense review).
• May manage / oversee investigator sites including CRA responsibilities on a temporary or permanent basis.

Project Liaison

Study Documents and Plans

Qualifications

Other

Working Conditions

#J-18808-Ljbffr