German Speaking Sponsor dedicated Site Start-Up Specialist based in Europe
Fortrea · Munich, Bavaria, DE
Join Our Team and Drive Clinical Research Success! We are looking for German speaking candidates based in one of the following countries: Switzerland, UK, Po...
Job description
Join Our Team and Drive Clinical Research Success! We are looking for German speaking candidates based in one of the following countries: Switzerland, UK, Poland, Hungary, Germany, Romania, Denmark, Czechia At Fortrea , we are committed to accelerating clinical trials and ensuring regulatory compliance. As a Site Start-Up Specialist , you will play a pivotal role in coordinating site start-up activities, managing essential documents, and ensuring regulatory submissions are completed efficiently. Your expertise will help bring life-changing treatments to patients faster. In this role, you will be part of our FSPx team and work directly with one of our renowned key sponsor to advance the development of innovative, life-changing medications. Key Responsibilities: In this role, you will: Serve as the primary contact for investigative sites during start-up and maintenance activities. Collect, review, and organize essential documents required for regulatory submissions (EC/IRB/Third Body/Regulatory Authority). Ensure compliance with ICH/GCP guidelines, regulatory requirements, and sponsor specifications. Prepare and submit regulatory documents, including country-specific application form...