SSU
Core
Coordinate local regulatory submissions and site start-up activities for clinical trials to align with global strategies and ensure compliance.
Role type
Senior Clinical Trial Regulatory Specialist (Local)
Builds
Regulatory submission packages, country-specific study files, and site activation readiness.
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Regulatory submission processes, project coordination, site start-up management, document development (PIS/ICF), feasibility coordination, database management, budget negotiation support
Preferred skills
Knowledge of MoH and EC regulatory frameworks, PPD SOPs, client SOPs
Technologies
PPD tracking databases
Responsibilities
Prepare and review local regulatory submissions; Provide local regulatory strategy advice; Coordinate site start-up activities; Develop country-specific Patient Information Sheets and Informed Consent forms; Support grant budget negotiations; Maintain trial status information in tracking databases; Ensure local study files are prepared per SOPs
