Country Approval Specialist
Core
Prepare, review, and coordinate country submissions for clinical trials in alignment with global strategy.
Role type
Country Approval Associate (Clinical Trial Operations)
Builds
Regulatory and Ethical submission packages for clinical study sites
Domain
Life Sciences / Clinical Research / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory guideline knowledge, submission coordination, site start-up alignment, budget negotiation, document preparation, database management, SOP compliance
Preferred skills
Medical terminology knowledge, investigator contact experience, grant budget management
Technologies
Clinical trial tracking databases, submission management systems
Responsibilities
Prepare and review local Ethical Committee (EC) and Ministry of Health (MoH) submissions; Coordinate with internal departments to align site start-up activities with submission timelines; Maintain trial status information in tracking databases; Assist in developing Patient Information Sheets and Informed Consent forms; Negotiate grant budgets and payment schedules with sites; Ensure local study files comply with SOPs.
