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.

Key responsibilities

• Plan, implement, and manage projects in compliance with ICH‑GCP, industry regulations and PSI quality documents.
• Act as primary or secondary project management contact for the team and PSI support services in the region.
• Collect and report project status updates, develop planning documents and manage KPIs for designated countries.
• Coordinate site contractual startup, budget negotiations and investigator payments.
• Supervise site selection, initiation, monitoring, close‑out visits and audit preparation.
• Oversee safety information flow, regulatory submissions and expense approvals.

Required profile

• College/University degree in Life Sciences or equivalent experience.
• Prior experience in clinical research, on‑site monitoring and study management, preferably in the US.
• Demonstrated experience as a Study Manager/Clinical Trial Manager with regional supervisory responsibilities.
• Experience in Oncology (required) and Gastro‑Intestinal therapeutic areas (preferred).
• Full professional proficiency in English.

Required skills

• Proficiency with MS Office applications.
• Proficiency with MS Project for project planning.