Conflicts and records specialist supporting Torys’ legal risk, business intake, and records management processes. Conducting conflict searches, KYC reviews, reporting, and file administration.
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
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