Especialista Start-up Estudos Clinicos
Core
Coordinate local ethical committee and regulatory submissions, manage study start-up and activation of research centers, and ensure compliance with global and local regulations for clinical trials.
Role type
Senior Clinical Study Start-Up Specialist
Builds
Clinical trial sites and studies
Domain
Clinical research / Healthcare
Required skills
Clinical trial regulations, Ethical committee submissions, Study start-up management, Risk assessment, Process improvement, Team leadership, ICH/GCP guidelines, Vault SSU management, Remote team collaboration, Analytical thinking
Preferred skills
Health or scientific degree, 2+ years in Study Start-Up management, Experience with central and local research centers, Experience with IRB/EC document review, Experience with investigational product import/export
Technologies
Vault SSU
Responsibilities
Prepare and coordinate local ethical and regulatory submissions, Establish country and center activation plans, Execute study start-up and maintenance activities, Manage critical path dependencies for approvals and contracts, Provide regulatory strategy guidance to internal clients, Maintain SSU performance metrics and KPIs, Lead process improvement initiatives, Train and mentor junior team members, Ensure readiness for audits and inspections, Support coordination of investigational product logistics
Seniority
Senior, hands-on IC