Clinical Regional Project Lead

About the role

PSI is seeking a senior Clinical Regional Project Lead to oversee and coordinate clinical trial activities across designated countries. The role ensures consistent Clinical Operations processes, meets study milestones, and drives successful project delivery within the region.

Key responsibilities

• Plan, implement, and manage projects in compliance with ICH‑GCP, industry regulations, and sponsor quality systems.
• Act as primary or secondary project management contact for the regional team and PSI support services.
• Collect, review, and report project status updates and key performance indicators for the region.
• Coordinate site contractual startup, budget negotiations, and investigator payments.
• Supervise site selection, initiation, monitoring, and close‑out visits, including audit/inspection preparation.
• Oversee regulatory and ethics committee submissions and safety information flow.
• Identify, escalate, and resolve resourcing and performance issues within the team.

Required profile

• University degree in Life Sciences or equivalent education and experience.
• Significant prior experience in clinical trial management within a CRO or pharmaceutical environment.
• Proven ability to lead multi‑country project teams and manage complex timelines.
• Strong understanding of ICH‑GCP, regulatory requirements, and clinical operations processes.

Required skills

• ICH‑GCP compliance