Regional Clinical Project Lead – Oncology Trials

Psi CRO; Bogotá; On-site; COP 120,000,000 - 180,000,000; Full time

Job summary

PSI is seeking a Regional Project Lead to oversee clinical trial activities across designated countries, ensuring alignment with ICH-GCP and PSI QMS documents while driving study milestones.

The role requires life sciences degree, on-site monitoring experience including the US, oncology focus, strong English, and proven leadership to coordinate budgets, KPIs, site start-ups, and audits. You will collaborate with investigators and manage data to report progress.

Qualifications

• College/University degree in Life Sciences or equivalent.
• Experience in Clinical Research and on-site monitoring required.
• Experience monitoring within the US is required.
• Study/Trial Manager experience with ability to supervise regional activities.
• Oncology experience is required; GI is a plus.

Responsibilities

• Oversee planning, implementation and management of projects per ICH-GCP and PSI documents.
• Act as primary or secondary PM contact for the project team and PSI support.
• Conduct study status reviews and report progress to leadership.
• Track and report KPIs for designated regions and team members.
• Ensure timelines and enrollment targets are met in country operations.
• Coordinate site contracting, startup and budget negotiations.
• Lead training for Investigators and field monitors as needed.
• Support regulatory submissions and audits; manage issue resolution.

Skills

Clinical Research Experience

On-site Monitoring

US Monitoring Experience

Study/Trial Management

Oncology Knowledge

GI Knowledge

English Proficiency

Communication Skills

Negotiation

Leadership

Team Building

Education

Life Sciences Degree

Tools

MS Office

MS Project

Job description

PSI is seeking a Regional Project Lead to oversee clinical trial activities across designated countries, ensuring alignment with ICH-GCP and PSI QMS documents while driving study milestones.

The role requires life sciences degree, on-site monitoring experience including the US, oncology focus, strong English, and proven leadership to coordinate budgets, KPIs, site start-ups, and audits. You will collaborate with investigators and manage data to report progress.