Regional Project Lead

In this role you will streamline activities of project teams and ensure consistency of Clinical Operations processes across North America. You will ensure meeting study milestones by project teams on a country level, report study progress to clients and global stakeholders.

The scope of responsibilities will include:

• Act as project management contact for the project team and PSI support services.
• Perform study status review and progress reporting, collect and report project status updates.
• Develop and update project planning documents, essential study documents and project manuals/ instructions.
• Ensure that the project timelines and subject enrollment targets are met.
• Coordinate maintenance of study-specific and corporate tracking systems.
• Oversee site selection and startup, site contractual and budget negotiations.
• Supervise project team and site training, perform field training of monitors tailored to the project needs.
• Ensure team compliance with project-specific training matrix.
• Supervise preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visits.
• Review site visit reports and ensures monitoring and reporting standards are met.
• Oversee investigator and site payments.
• Supervise project team preparation for study audits/ inspections and resolution of audit/ inspection findings.
• Might be involved in regional project oversight for NA.

• MPharm, RN or university/college degree in Life Sciences or an equivalent combination of education, training and experience.
• Minimum 4 years’ site monitoring experience and at least 2 years’ experience as Lead Monitor.
• Experience supervising clinical project activities and leading clinical project teams.
• Experience in oncology, gastroenterology, infectious diseases, autoimmune diseases, or any rare disease indication is preferable.
• Communication, presentation, and customer-service skills.
• Team building, leadership and organizational skills.
• Full working proficiency in English.
• Proficiency in MS Office applications, including MS Project.

For this position, PSI is not hiring individuals who require work visa sponsorship for employment now or in the future.

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