PSI is a leading Contract Research Organization (CRO) with over 25 years of experience in the pharmaceutical industry. Originating from Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.

In an industry where cost-cutting and layoffs are common, PSI stands out as a stable and secure workplace. Our dedication to stability is evident in our exceptionally high repeat and referral business rate and minimal staff turnover. More than 25% of our colleagues have been with us for over 10 years, contributing to our long-standing traditions and history. Our expansion into Japan continues this legacy, and we seek team members who will grow with us for the long term.

At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.

We are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry.

In this role you will streamline activities of project teams in Japan and ensure consistency of Clinical Operations processes across regions. 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:

• 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
• 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) 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, 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

• 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 Japan
• 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

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.