Clinical Regional Project Lead

PSI CRO

9d

About The Position

The Regional Project Lead is a senior-level clinical trial manager who oversees, manages, and coordinates project team activities in designated countries and supports consistency of Clinical Operations processes across regions. The role helps ensure that project teams meet study milestones at country and regional levels and that projects are planned and managed in compliance with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents.

The Regional Project Lead may serve as a primary or secondary project management contact for project teams and PSI support services in designated countries. Responsibilities include reviewing study status and progress, collecting and reporting regional updates, maintaining project documentation and tracking systems, monitoring key performance indicators, and supporting country timelines and subject enrollment targets.

The role also coordinates site startup and budget negotiations, establishes project-team communication, supervises clinical project team members, and supports training. It oversees site selection, initiation, monitoring, and closeout activities; investigator and site payments; CRF data handling and query resolution; audit and inspection preparation and follow-up; regulatory and ethics committee submissions; safety information flow; feasibility research; and, where delegated, project expenses and timesheets.

Requirements

• College or university degree in Life Sciences, or an equivalent combination of education, training, and experience.
• Prior experience in clinical research and on-site monitoring.
• Prior experience monitoring within the US.
• Experience as a Study Manager or Clinical Trial Manager, with the ability to supervise project activities as a Regional Lead or equivalent.
• Experience in Oncology.
• Full working proficiency in English.
• Proficiency in MS Office applications, including MS Project.
• Communication, presentation, and customer-service skills.
• Ability to negotiate and build relationships at all levels.
• Team-building, leadership, and organizational skills.

Nice To Haves

• Experience in GI.

Responsibilities

• Ensure planning, implementation, and management of projects comply with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents.
• Act as primary or secondary project management contact for project teams and PSI support services in designated countries.
• Review study status and progress reporting when delegated by the Project Manager.
• Collect and report project status updates for designated regions, internally and externally.
• Develop and update project planning documents, essential study documents, and project manuals or instructions.
• Manage and report key performance indicators for designated countries and clinical project team members.
• Ensure project timelines and subject enrollment targets are met in designated countries.
• Coordinate maintenance of study-specific and corporate tracking systems.
• Coordinate site contractual startup and budget negotiations.
• Establish project-team communication lines and supervise clinical project team members’ performance.
• Identify, escalate, and resolve resourcing and performance issues.
• Conduct and supervise therapeutic-area training for the project team when delegated by the Project Manager.
• Prepare presentations and conduct Investigator training.
• Ensure team compliance with the project-specific training matrix.
• Conduct project-tailored field training for Monitors.
• Supervise preparation, conduct, and reporting of site selection, site initiation, routine monitoring, and closeout visits.
• Oversee investigator and site payments, CRF data retrieval and upload, monitoring, and query resolution.
• Supervise project-team preparation for study audits and inspections and resolution of findings.
• Coordinate supervised monitoring visits.
• Review site visit reports and ensure monitoring and reporting standards are met.
• Coordinate preparation of initial and follow-up Regulatory and Ethics Committee submissions and notifications.
• Oversee safety information flow and participate in feasibility research.
• Review and approve project-related expenses and timesheets when delegated by the Project Manager.

Benefits

• Opportunity to advance a career in clinical research.
• Opportunity to coordinate a variety of tasks and learn new things while growing with the company.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior