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About the role

  • Regional Project Lead coordinating North American clinical trials for PSI, a global contract research organization. Overseeing project teams, study milestones, sites, training, payments, and audits.

Responsibilities

  • Streamline project team activities and ensure consistency of Clinical Operations processes across North America
  • Act as project management contact for project teams and PSI support services
  • Review study status and report progress to clients and global stakeholders
  • Collect and report project status updates
  • Develop and update project planning documents, essential study documents, and project manuals/instructions
  • Ensure project timelines and subject enrollment targets are met
  • Coordinate maintenance of study-specific and corporate tracking systems
  • Oversee site selection and startup, contractual negotiations, and budget negotiations
  • Supervise project team and site training, including field training of monitors
  • Ensure compliance with project-specific training matrices
  • Supervise site selection, site initiation, routine monitoring, and closeout visits
  • Review site visit reports and ensure monitoring and reporting standards are met
  • Oversee investigator and site payments
  • Supervise preparation for study audits/inspections and resolution of findings
  • Participate in regional project oversight for North America

Requirements

  • MPharm, RN, or university/college degree in Life Sciences, or equivalent combination of education, training, and experience
  • Minimum 4 years' site monitoring experience
  • 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 rare disease indications 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
  • Must not require work visa sponsorship for employment now or in the future

Benefits

  • Stable and secure workplace
  • Inclusive culture where colleagues feel welcomed and valued
  • Professional development and career success investment

Job title

Job type

Full Time

Experience level

Senior

Salary

CA$140,000 - CA$155,000 per year

Degree requirement

Bachelor's Degree

Location requirements

RemoteCanada

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