About this role

Perform tasks at a country level associated with Site Activation (SA) activities
Ensure adherence to standard operating procedures (SOPs)
Serve as Single Point of Contact (SPOC) in assigned studies
Perform start-up and site activation activities
Distribute completed documents to sites and teams
Prepare site regulatory documents, ensuring completeness and accuracy
Maintain internal systems, databases, and tracking tools
Review and provide feedback on site performance metrics
Review, track, and follow-up on document approvals and executions
Provide local expertise to SAMs and project team

Bachelor’s Degree in life sciences or a related field
3 years’ clinical research or other relevant experience
In-depth knowledge of clinical systems, procedures, and corporate standards
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
Knowledge of applicable regulatory requirements, including local regulations, SOPs, and company’s Corporate Standards
Understanding of regulated clinical trial environment
Knowledge of drug development process

Regulatory and Start Up Specialist

Key skills