Country Approval Specialist - FSP- Israel
Core
Manage and coordinate local regulatory submissions to activate investigative sites for clinical trials.
Role type
Country Approval Specialist (Clinical Research)
Builds
Site activation for clinical studies
Domain
Clinical research / Pharmaceutical services
Deliverable
client delivery
Required skills
Regulatory submission coordination, local regulatory strategy advice, project coordination, data explanation, clinical protocol knowledge, organizational skills, decision making, negotiation, Microsoft Office proficiency
Preferred skills
Medical/therapeutic area knowledge, regional/national regulatory guidelines knowledge
Technologies
PPD tracking databases
Responsibilities
Prepare, review, and coordinate local regulatory submissions (MoH, EC, special national applications); Provide local regulatory strategy advice; Coordinate site start-up activities with internal departments; Maintain trial status information in tracking databases; Ensure local country study files are prepared per SOPs; Support feasibility activities.
Seniority
Mid-level, hands-on IC
