Regional Project Lead

Psi-Cro; Toronto; On-site; CAD 140,000 - 155,000; Full time

Job summary

PSI, a leading global CRO, seeks an experienced Clinical Operations professional to streamline activities across North America, ensuring milestones are met and reporting progress to clients and global stakeholders. The role emphasizes site monitoring leadership, project planning, and cross-functional coordination.

The candidate will oversee site initiation, monitoring, and oversight of audits, working with multi-disciplinary teams to ensure compliant, timely trial delivery in North America.

Qualifications

• Strong communication and customer-service skills.
• Team leadership and organizational abilities.
• Proficiency in MS Office incl. MS Project.

Responsibilities

• Act as project management contact for the project team and PSI support services.
• Perform study status reviews and progress reporting; collect and report updates.
• Develop and update project planning documents and essential study materials.
• Ensure project timelines and subject enrollment targets are met.
• Coordinate maintenance of study-specific and corporate tracking systems.
• Oversee site selection, startup, and budget negotiations.
• Supervise site training and monitoring activities; ensure training matrix compliance.
• Prepare for and participate in audits/inspections; resolve findings.

Skills

Communication

Presentation

Customer service

Team building

Leadership

Education

MPharm, RN or Life Sciences degree

Tools

MS Office / MS Project

Job description

• Compensation: CAD 140,000 - CAD 155,000 - yearly

Company Description

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.

Job Description

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.

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.

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 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.

Additional Information