REGIONAL PROJECT LEAD

<p>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.</p><p><strong>The scope of responsibilities will include:</strong></p><ul><li>Act as project management contact for the project team and PSI support services.</li><li>Perform study status review and progress reporting, collect and report project status updates.</li><li>Develop and update project planning documents, essential study documents and project manuals/ instructions.</li><li>Ensure that the project timelines and subject enrollment targets are met.</li><li>Coordinate maintenance of study-specific and corporate tracking systems.</li><li>Oversee site selection and startup, site contractual and budget negotiations.</li><li>Supervise project team and site training, perform field training of monitors tailored to the project needs.</li><li>Ensure team compliance with project-specific training matrix.</li><li>Supervise preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visits.</li><li>Review site visit reports and ensures monitoring and reporting standards are met.</li><li>Oversee investigator and site payments.</li><li>Supervise project team preparation for study audits/ inspections and resolution of audit/ inspection findings.</li><li>Might be involved in regional project oversight for NA.</li></ul> <ul><li>MPharm, RN or university/college degree in Life Sciences or an equivalent combination of education, training and experience.</li><li>Minimum 4 years’ site monitoring experience and at least 2 years’ experience as Lead Monitor.&#xa0;</li><li>Experience supervising clinical project activities and leading clinical project teams.</li><li>Experience in oncology, gastroenterology, infectious diseases, autoimmune diseases, or any rare disease indication is preferable.</li><li>Communication, presentation, and customer-service skills.</li><li>Team building, leadership and organizational skills.</li><li>Full working proficiency in English.&#xa0;</li><li>Proficiency in MS Office applications, including MS Project.</li></ul> <p><strong><em>For this position, PSI is not hiring individuals who require work visa sponsorship for employment now or in the future.</em></strong></p><p>Make the right call and take your career to a whole new level.&#xa0;Join the company that focuses on its people and invests in their professional development and success.</p>