Clinical Regional Project Lead

About the role

The Clinical Regional Project Lead is a senior clinical trial manager responsible for overseeing project teams across designated countries. This role ensures that clinical operations are consistent, compliant, and delivered on schedule within the region.

Key responsibilities

• Plan, implement, and manage clinical projects in line with ICH‑GCP, regulatory requirements and sponsor quality systems.
• Act as primary or secondary project manager contact for the regional team and PSI support services.
• Collect, consolidate and report project status, KPIs and enrollment metrics for the region.
• Coordinate site start‑up activities, budget negotiations and contractual agreements.
• Supervise site selection, initiation, monitoring, close‑out visits and ensure data quality through CRF retrieval and query resolution.
• Oversee investigator payments, safety information flow and preparation for audits/inspections.
• Lead therapeutic area training, investigator presentations and field training for monitors.
• Review and approve project‑related expenses and timesheets where delegated.

Required profile

• University degree in Life Sciences or equivalent education and experience.
• Significant prior experience in clinical trial management, preferably within a CRO environment.
• Proven ability to manage multi‑country projects and lead cross‑functional teams.
• Strong knowledge of regulatory and ethics committee submission processes.

Required skills

• ICH‑GCP compliance
• Regulatory submissions and ethics committee coordination
• CRF data retrieval and upload
• Clinical monitoring and site management
• Budget negotiation and contract management