Regional Project Lead

Role Summary

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.

Requirements

The scope of responsibilities will include

• Act as project management contact for the project team and PSI support services.
• 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.
• 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.
• Might be involved in regional project oversight for NA.
• MPharm, RN or university/college degree in Life Sciences or an equivalent combination of education, training and experience.
• Minimum 4 years’ site monitoring experience and 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.

PSI is a leading Contract Research Organization (CRO) with over 30 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.

• 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.

About the Company

Why Join PSI?

At PSI, we believe exceptional people deserve an exceptional workplace.

When you join PSI, you'll benefit from

A stable, privately held CRO that has never undergone a merger or acquisition and has never experienced company-wide layoffs.

A unique leadership-focused CRA role with minimal travel and little to no routine site assignments.

Opportunities to mentor other CRAs and expand your leadership skills.

A collaborative, people-first culture where employees are genuinely supported.

Career development opportunities across a growing global organization.

The chance to contribute to innovative clinical research that improves patients' lives.

We are the company that cares - for our staff, our clients, our partners, and the quality of the work we do.

Founded in 1995, PSI CRO is a privately owned, global Contract Research Organization with more than 3,000 employees dedicated to advancing medical science and bringing new therapies to patients worldwide.

In an industry shaped by mergers, acquisitions, and restructures, PSI stands apart. We have remained privately held, have never undergone a merger or acquisition, and have never experienced company-wide layoffs. Our long-term stability allows us to invest in our people, foster meaningful careers, and build lasting partnerships with our clients.

If you're looking for a collaborative organization where you can continue to grow while making a meaningful impact, PSI is the right place for you.