Regional Project Lead

Company Description

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.

Job Description

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

Qualifications

• 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 1-2 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 and Japanese
• Proficiency in MS Office applications, including MS Project

Additional Information

How are we different?

PSI is privately owned by the very people who founded the company more than 25 years ago, and they’re still working here today. As a result, we have grown organically around the globe and have kept our company fully independent, giving us significant advantages and freedoms.  

Being a Part of the Team

As a part of the PSI team, you will have a fair degree of ownership and autonomy to make nuanced country-and department-specific adjustments while nurturing the global PSI culture that unites us across six continents.

You will receive continuous support from your global peers and join a fast-paced, innovative, and results-oriented working environment with lean communication lines. We pride ourselves on being approachable, receptive to new ideas, and open to feedback.

Growth Opportunities

PSI is proud to invest in our people, from entry-level team members to senior leaders, helping you identify and hone your unique strengths at every step of your career. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.

PSI is an inclusive and equal opportunity employer and is committed to attracting and retaining a diverse workforce that reflects the community we serve.

Videos To Watch