Project Manager II, dermatology and rheumatology CRO,USA
Core
Manage initiation, planning, execution, monitoring, and closure of dermatology and rheumatology clinical trials (Phase I-III) for a CRO, serving as the primary liaison with sponsors.
Role type
Senior clinical trial project manager
Builds
Clinical study deliverables including study plans, protocols, eCRFs, clinical study reports, and TMFs for multisite global Phase III projects
Domain
Clinical research / Dermatology and Rheumatology
Required skills
Clinical trial project management, GCP/ICH standards, FDA/Canadian regulations, budget control, multi-center trial leadership, vendor management, risk management
Preferred skills
Dermatology trial experience, French language proficiency
Technologies
Microsoft Office suite
Responsibilities
Lead study start-up activities including site selection, activation, and contracting; oversee project team including associate managers and coordinators; manage project budget and timelines; ensure audit readiness and quality of deliverables; serve as primary contact for the sponsor; coordinate with Regulatory Affairs, Data Management, and Clinical Monitoring teams
Seniority
Senior, hands-on IC