Clinical Trial Manager II, Dermatology & Rheumatology
Core
Operational management and oversight of clinical investigative sites and clinical operations deliverables for dermatology and rheumatology trials.
Role type
Senior Clinical Trial Manager (IC) (via careerplan.io/jobs/15-003-C2-278-clinical-trial-manager-ii-dermatology-rheumatology)
Builds
Clinical trials for dermatology and rheumatology therapeutic areas
Domain
Clinical Research / Contract Research Organization (CRO)
Deliverable
client delivery
Required skills
Clinical monitoring oversight, site performance management, protocol adherence, risk assessment, budget tracking, CRA training and mentoring, quality assessment, study plan development
Preferred skills
Business development support, process improvement, complex issue resolution
Technologies
ICH/GCP guidelines, SOPs, monitoring tools (SQV, SIV, SMV, COV)
Responsibilities
Ensure clinical monitoring activities comply with sponsor contracts and regulations; Identify quality issues and trends in site performance; Manage risk assessment and mitigation; Provide training and oversight to CRAs and Lead CRAs; Coordinate CRA meetings and conduct quality assessment visits; Track site visit report metrics and manage site screening/enrollment; Manage project budget tracking, forecasting, and reconciliation; Contribute to business development activities and process improvements.
Seniority
Mid-Senior, hands-on IC with mentorship responsibilities