ICF Specialist
Core
Review, coordinate, and finalize Global Informed Consent Form (ICF) templates for clinical studies managed by Development Operations, including country-level site activation support.
Role type
Senior Clinical Operations Specialist (ICF & Site Activation)
Builds
Validated ICF templates and regulatory documents for clinical trial sites
Domain
Clinical Research / Life Sciences / Regulatory Affairs
Required skills
ICF review and validation, Site Activation (SA) execution, EU/EEA regulatory compliance, CTIS system navigation, GCP/ICH guidelines application, Clinical trial lifecycle management, Document quality control, Project timeline planning, Regulatory document preparation
Preferred skills
AI tool usage (Copilot), Cross-functional negotiation, Investigative site communication, Performance metrics analysis
Technologies
CTIS, Internal clinical systems, Databases, Tracking tools
Responsibilities
Check ICFs against protocols and samples plans; Review country-specific ICFs for accuracy; Resolve RFI/EC queries; Track ICF review progress; Manage centralized ICF mailbox; Perform site startup and activation; Distribute regulatory documents to sites; Maintain internal databases; Review site performance metrics; Plan project timelines; Implement monitoring measures and contingency plans; Provide local expertise to Site Activation Managers.
