Specialist, Country Study Start Up
Core
Proactively drives and executes all start-up and maintenance-related activities and deliverables for assigned studies and sites in their assigned country or countries.
Role type
Senior IC clinical research start-up specialist
Builds
Site activation plans, ethics submissions, and clinical supply shipments for assigned studies
Domain
Clinical research / Healthcare
Required skills
Clinical research regulations interpretation, IRB/EC submission management, Investigational Product (IP) release, Interactive Voice/Web Response System (IXRS) activation, process improvement, training and mentoring, data management (Vault SSU), regulatory compliance (ICH/GCP)
Preferred skills
Bachelor's degree in Health Care or Science, experience with central and local IRB/EC sites, experience working with remote/virtual teams
Technologies
Vault Study Start-Up (SSU), Interactive Voice/Web Response System (IXRS)
Responsibilities
Establish country/site activation plans and priorities including risk assessment and mitigation plans, Compile and submit ethics and other required local submissions including customization of Informed Consent Forms (ICFs), Coordinate with Regulatory and CMS on Competent Authorities (CA) submission and approval status, Facilitate clinical supply shipments and complete Investigational Product (IP) release activities, Issue site green light letter and activating sites in Interactive Voice/Web Response System (IXRS), Track all start-ups and maintenance-related activities in Vault Study Start-Up (SSU), Provide start up updates and metrics to CCOM/COM and Area SSU and CSM Leads, Drive to improve site start-up efficiency by leading process improvement initiatives, Function as an SME in the SSU community and leads training and mentoring of Country Start Up Specialists
Seniority
Senior, hands-on IC
