Senior Project Coordinator / Coordonnateur principal de projet, North America
Core
Provides administrative and coordinating support for site activation activities and site-level deliverables throughout the clinical trial lifecycle.
Role type
Senior Project Coordinator (Clinical Research)
Builds
Site activation timelines, essential clinical trial documentation, and study files for biotechnology and pharmaceutical clients.
Domain
Clinical research, biotechnology, pharmaceutical, CRO
Required skills
Site start-up management, essential documentation review, regulatory compliance knowledge, document collection and filing, meeting minutes production, payment reconciliation, study material inventory management, training coordination
Preferred skills
Mentorship of junior coordinators, process improvement, training material creation
Technologies
eTMF, Word, Excel, PowerPoint (via careerplan.io/jobs/15-003-DE-07C-senior-project-coordinator-coordonnateur-principal-de-projet-north-america)
Responsibilities
Prepare investigator sites by reviewing and approving essential clinical trial and regulatory documents; Establish site activation timelines and coordinate activities to meet planned targets; Communicate with clinical sites during start-up; Collaborate with functional departments to align activities with activation targets; Escalate risks to site activation schedules; Collect, review, and file essential site documents; Ensure eTMF contains relevant regulatory documents; Distribute study correspondence and study supplies to sites; Assist with local ethics submissions and Health Authority inspection support; Maintain project timelines, enrollment tracking tools, and study material inventory; Mentor junior project coordinators.
Seniority
Senior, hands-on IC with mentorship responsibilities