Ctry Approval Spec
Core
Manage and coordinate local regulatory submissions for clinical trial study startup across multiple countries to ensure alignment with global strategy and timely site activation.
Role type
Country Approval Specialist (Clinical Operations)
Builds
Clinical trial startup services for commercial and government contracts
Domain
Clinical research services / Life sciences
Deliverable
client delivery
Required skills
Regulatory submission coordination, local regulatory strategy advice, project coordination, database management, SOP compliance, negotiation, medical terminology knowledge
Preferred skills
Knowledge of regional/national regulatory guidelines, EC regulations, feasibility activities
Technologies
Company tracking databases, standard office equipment
Responsibilities
Prepare and coordinate local regulatory submissions (MoH, EC, special national applications); Provide local regulatory strategy advice; Coordinate site startup activities and align with critical path; Maintain trial status information in tracking databases; Ensure country study files comply with company/client SOPs; Support feasibility activities and grant budget negotiations.
Seniority
Mid-level, individual contributor
