IVDR Study Start-Up Associate - UK
About this role
Job title: IVDR Study Start-Up Associate - UK
About the Role Join ICON as an IVDR Study Start-Up Associate in the UK. You will play a key role in the successful start-up and activation of In Vitro Diagnostics (IVD) clinical studies, partnering with cross-functional teams, investigative sites, and regulatory stakeholders to ensure studies are initiated efficiently and in compliance with applicable regulations and timelines.
What You'll Do
- Preparing, compiling, and submitting regulatory and ethics documentation, including clinical trial applications and ethics committee submissions.
- Coordinating with internal teams, sponsors, regulatory authorities, and investigative sites to secure required approvals and authorisations for study initiation.
- Maintaining accurate and inspection-ready records of regulatory submissions, approvals, and essential study documents.
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