Study Start-Up Analyst

Be the catalyst that brings clinical trials to life. Navigate regulatory complexities, partner with health authorities and ethics committees, and ensure studies launch successfully.

Your new role

As a Study Start-Up Analyst, you'll own the end-to-end execution of study start-up and submission activities for assigned clinical trials. You'll be the regulatory expert who ensures everything is in place for trials to launch on time and in full compliance.

Responsibilities

• Leading the preparation, review, and submission of Health Authority (HA) and Ethics Committee (EC) dossiers, ensuring compliance with ICH GCP regulations and local requirements
• Obtaining regulatory documentation and requirements to initiate studies—navigating ethics committee requirements, submitting to authorities, and strategically managing objections
• Driving internal approvals for labels and documents, including the customization, translation, and valid...