Review and approve Critical Document Packages (CDPs) prior to IP release, ensuring compliance with ICON and Sponsor SOPs, ICH/GCP principles, and applicable country regulations
Job Summary
Review and approve Critical Document Packages (CDPs) prior to IP release, ensuring compliance with ICON and Sponsor SOPs, ICH/GCP principles, and applicable country regulations.
This position offers an excellent opportunity to build expertise in clinical document management and contribute to operational excellence within a global organization.
Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Matching Summary
Review and approve Critical Document Packages (CDPs) prior to IP release, ensuring compliance with ICON and Sponsor SOPs, ICH/GCP principles, and applicable country regulations.
Skills & Requirements
Must-have
review study start-up documents
Contract QC experience
review and approve Critical Document Packages
ICH/GCP principles
ICON SOPs/WPs
Nice-to-have
Subject Matter Expert
process improvement initiatives
mentor and coach new hires
cross-functional communication
Key Requirements
1–3 years of experience in clinical research
Bachelor’s degree in Life Sciences or related field