Clinical Regional Project Lead

About the role

The Regional Project Lead is a senior clinical trial manager responsible for overseeing project teams across designated countries, ensuring consistent Clinical Operations processes and timely achievement of study milestones.

Key responsibilities

• Plan, implement and manage projects in compliance with ICH‑GCP, industry regulations and internal quality systems.
• Act as primary or secondary project management contact for the team and PSI support services in the region.
• Collect and report project status updates, manage KPIs, and ensure enrollment targets and timelines are met.
• Coordinate site contractual startup, budget negotiations, and oversee site payments, CRF data handling and query resolution.
• Supervise site selection, initiation, monitoring, close‑out visits and preparation for audits/inspections.
• Lead therapeutic area training, investigator presentations and ensure compliance with the project training matrix.

Required profile

• University degree in Life Sciences or equivalent experience.
• Prior clinical research and on‑site monitoring experience, including US monitoring.
• Experience as a Study Manager/Clinical Trial Manager with supervisory responsibilities.
• Background in Oncology (required) and preferably Gastro‑Intestinal studies.
• Full professional proficiency in English.

Required skills

• Proficiency with MS Office applications.
• Proficiency with MS Project.