PSI CRO
pharmaceutical
RegionalProjectLead
“Regional Project Lead at PSI CRO. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement, Communication, presentation, customer-service skills, Team building, leadership, organizational skills. streamline activities of project teams in Japan. ensure consistency of Clinical Operations processes across regions”
What You'll Achieve.
ensure meeting study milestones by project teams on a country level; report study progress to clients and global stakeholders; Ensure that the project timelines and subject enrollment targets are met; Supervise clinical project team performance, manage, and report on Key Performance Indicators (KPIs) in Japan; ensures monitoring and reporting standards are met
Industry & Context.
What They're Looking For.
Must Have
Minimum 4 years’ site monitoring experience in Japan, At least 1-2 years’ experience as Lead Monitor, Experience supervising clinical project activities and leading clinical project teams, Full working proficiency in English and Japanese
Nice to Have
Experience in oncology, gastroenterology, infectious diseases, autoimmune diseases, or any rare disease indication is preferable
What You'll Do.
streamline activities of project teams in Japan
ensure consistency of Clinical Operations processes across regions
ensure meeting study milestones by project teams on a country level
report study progress to clients and global stakeholders
Coordinate project team work in Japan
Act as project management contact for the project team and PSI support services
Act as a contract for global clients
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
and report on Key Performance Indicators (KPIs) in Japan
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
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
How You'll Work.
Team & Collaboration
Coordinate project team work in Japan; Act as project management contact for the project team and PSI support services; Act as a contract for global clients, contractors, subcontractors and third-party vendors; report study progress to clients and global stakeholders; Supervise clinical project team performance; Supervise project team and site training; Supervise project team preparation for study audits/ inspections
Communication Scope
Communication; presentation
Process & Methodology
process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement, project planning documents, project manuals/ instructions, project timelines, project status updates
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