Regional Clinical Trial Lead - Strategy & Impact

PSI CRO; Ciudad de México; Presencial; MXN 900.000 - 1.100.000; Jornada completa

Descripción de la vacante

PSI CRO is seeking a Regional Project Lead to oversee and coordinate clinical trial activities across designated countries, ensuring milestones and regulatory compliance.

The role requires extensive experience in clinical research and on-site monitoring, with demonstrated ability to lead project teams and manage site initiation, monitoring, and budgeting. Proficiency in English and strong communication, negotiation, and leadership skills are essential.

Formación

• College/University degree in Life Sciences or equivalent required.
• Experience in Clinical Research and on-site monitoring required.
• Experience monitoring within the US is required.
• Experience as a Study Manager/Clinical Trial Manager with ability to supervise regional activities is required.
• Experience in Oncology is required; GI experience is preferred.
• Proficiency in MS Office applications including MS Project.
• Fluent in English with strong communication and presentation skills.
• Ability to negotiate and build relationships at all levels; strong leadership and team-building skills.

Responsabilidades

• Oversee, manage, and coordinate project activities in designated countries to ensure study milestones.
• Ensure compliance with ICH-GCP, essential study documents, and controlled documents.
• Conduct study status reviews and progress reporting as delegated.
• Collect and report project status updates for regions; manage KPIs.
• Develop planning documents, essential study documents, and project manuals.
• Coordinate site start-up, monitoring, and closeout visits; oversee budgets and payments.
• Train Investigators and project teams; ensure training matrices are followed.

Conocimientos

Clinical Research

On-site Monitoring

US Monitoring experience

Leadership

Communication

English proficiency

Negotiation

Team Building

Educación

College/University degree in Life Sciences

Herramientas

MS Project

MS Office

Descripción del empleo

PSI CRO is seeking a Regional Project Lead to oversee and coordinate clinical trial activities across designated countries, ensuring milestones and regulatory compliance.

The role requires extensive experience in clinical research and on-site monitoring, with demonstrated ability to lead project teams and manage site initiation, monitoring, and budgeting. Proficiency in English and strong communication, negotiation, and leadership skills are essential.