Senior Clinical Trial Manager (Sr CTM), Dermatology & Rheumatology, 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 (Sr CTM)
Builds
Clinical trials in dermatology and rheumatology
Domain
Clinical Research / Biotechnology / Pharmaceuticals
Required skills
Clinical monitoring, CRA training and mentoring, quality issue identification, action plan development, site visit report review, Clinical Monitoring Plan development, project-specific training, quality control visits, CRA meeting coordination, co-monitoring visits, business development support
Preferred skills
Dermatology experience, CRO experience
Technologies
Microsoft Office (Word, Excel, PowerPoint)
Responsibilities
Ensure clinical monitoring activities meet Sponsor satisfaction and regulatory requirements; Identify quality issues and trends related to site performance; Serve as point of contact for CRAs and Lead CRAs; Provide mentoring and oversight of CRAs; Review site visit reports and track metrics; Contribute to Clinical Monitoring Plan development; Prepare and conduct CRA training; Develop monitoring tools; Conduct quality control visits; Coordinate CRA meetings; Perform co-monitoring visits; Participate in business development activities.
Seniority
Senior, hands-on IC