Remote Regional Project Lead (Clinical Trials)

Summary

Join PSI as we strive to deliver high-quality, timely services across a broad spectrum of therapeutic indications by streamlining project team activities in India and ensuring consistency of Clinical Operations processes. As a Project Manager, you will be responsible for coordinating clinical project teamwork, acting as a contact for global clients, and overseeing site selection and startup.

Requirements

• MPharm, RN or university/college degree in Life Sciences or an equivalent combination of education, training and experience
• Minimum 4 years’ site monitoring experience in India
• At least 2 years’ experience as Lead Monitor
• Experience supervising clinical project activities and leading clinical project teams
• 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

Responsibilities

• Coordinate clinical project teamwork
• Act as project management contact for the project team and PSI support services
• Act as a contact for global clients, contractors, subcontractors and third-party vendors
• 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
• Supervise clinical project team performance, manage, and report on Key Performance Indicators (KPIs)
• 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