Study Start up Specialist, IQVIA Biotech
Core
Execute country-level Site Activation (SA) activities for clinical research studies, serving as the Single Point of Contact for investigative sites and ensuring adherence to regulations and SOPs.
Role type
Clinical research site activation specialist
Builds
Clinical research studies for life sciences and healthcare clients
Domain
Clinical research / Life sciences
Required skills
Site activation, regulatory document preparation, ICF review (US/Canada), internal system maintenance, project timeline management, quality control of site documents
Preferred skills
Adapting country ICFs for US/Canada regulatory requirements, site-specific ICF review, revised ICF in study maintenance
Responsibilities
Serve as SPOC for assigned studies, perform start-up and site activation activities, prepare and review site regulatory documents, maintain internal databases and tracking tools, review site performance metrics, track document approval and execution (ICF, Investigator Pack), provide local expertise to project teams, perform quality control of site-provided documents
Seniority
Entry-level, individual contributor
