Clinical Trial Manager II / Gestionnaire d’essais cliniques II, Canada, remote
Core
Operational management and oversight of clinical investigative sites and clinical monitoring deliverables for dermatology and rheumatology trials.
Role type
Senior Clinical Trial Manager (monitoring focus)
Builds
Clinical monitoring plans, quality control visits, and CRA training programs (via careerplan.io/jobs/15-003-22-E6E-clinical-trial-manager-ii-gestionnaire-dessais-cliniques-ii-canada-remote)
Domain
Biotechnology/Pharmaceuticals (Dermatology & Rheumatology)
Required skills
Clinical monitoring, CRA training and mentoring, quality issue identification, action plan development, site visit report review, regulatory compliance (ICH/GCP), project coordination
Preferred skills
Dermatology therapeutic area knowledge, CRO industry experience, business development
Technologies
Microsoft Office suite (Word, Excel, PowerPoint)
Responsibilities
Ensure clinical monitoring activities meet sponsor satisfaction and regulatory standards; Identify quality issues and trends in site performance; Serve as point of contact for CRAs and Lead CRAs; Provide mentoring and oversight to CRAs; Review site visit reports and track compliance metrics; Develop Clinical Monitoring Plans; Conduct project-specific training for CRAs; Perform quality control visits and co-monitoring visits with CRAs; Coordinate and lead CRA meetings
Seniority
Senior, hands-on IC