Country Approval Specialist / Sr Country Approval Specialist
Core
Coordinate site activation and regulatory submissions to ensure efficient clinical trial start-up in compliance with local regulations.
Role type
Senior IC clinical operations specialist (site activation & regulatory)
Builds
Clinical trial start-up activities for pharmaceutical and biotechnology clients
Domain
Clinical research / Regulatory affairs
Deliverable
client delivery
Required skills
Clinical trial start-up processes, Regulatory submissions, Site activation strategies, ICH-GCP guidelines, Ethics committee interactions, Site agreement management, Trial status tracking, Process improvement
Preferred skills
Global regulatory requirements knowledge, Stakeholder management, Negotiation, Problem-solving, Mentoring, Clinical trial management systems
Technologies
Microsoft Office, Clinical trial management systems
Responsibilities
Coordinate site activation activities to achieve study start-up timelines, Prepare and manage regulatory submissions to authorities and ethics committees, Support country-specific regulatory strategies, Maintain site and regulatory documentation, Assist with site agreement negotiations, Collaborate with investigators and sponsors to facilitate approvals, Ensure compliance with SOPs and ICH-GCP guidelines, Monitor trial status information, Support inspection readiness activities, Identify and resolve regulatory or start-up issues
Seniority
Senior, hands-on IC
