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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