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. You will ensure consistent Clinical Operations processes, meet study milestones, and drive successful execution of clinical studies within the region.

Key responsibilities

• Plan, implement and manage projects in compliance with ICH‑GCP, regulatory requirements and internal SOPs.
• Act as primary or secondary project management contact for the team and PSI support services in the assigned countries.
• Collect, consolidate and report project status updates, KPIs and enrollment targets to internal and external stakeholders.
• Coordinate site contractual start‑up, budget negotiations and site monitoring activities.
• Supervise preparation, conduct and reporting of site selection, initiation, routine monitoring and close‑out visits.
• Oversee investigator and site payments, CRF data retrieval, query resolution and safety information flow.
• Lead preparation for regulatory and ethics committee submissions, audits and inspections.
• Provide training to investigators, monitors and project team members as required.

Required profile

• University degree in Life Sciences or equivalent combination of education and experience.
• Significant prior experience in clinical trial management within a CRO or pharmaceutical environment.
• Proven ability to manage multi‑country projects and lead cross‑functional teams.
• Strong understanding of ICH‑GCP, regulatory requirements and clinical study documentation.

Required skills

• ICH‑GCP compliance
• Clinical trial management
• Budget negotiation
• Site monitoring and oversight
• Regulatory submissions and ethics committee interactions