Study Start-up Specialist, Türkiye

Job description

This is an exciting opportunity to be a part of the team which you will execute of all study start-up and submission activities. Your new position: As Study Start-Up (SSU) Specialist you will be responsible for high-quality execution of all study start-up and submission activities at the country and site level for assigned trials, ensuring timely site activation and regulatory compliance. You will drive cross-functional collaboration with study teams, vendors, and external stakeholders to ensure efficient trial initiation, regulatory submissions, and timely site activation Some of your responsibilities will be to: Authority (HA) and/or Ethics Committee (EC) dossiers, ensuring compliance with ICH GCP regulations, local requirements, and Novo Nordisk processes. - Lead, coordinate and manage the preparation, review and submission of Health - Co-develop regulatory strategy and SSU plans for assigned trials with TMs and SSU Manager, in alignment with CDC strategy and industry best practice. - Perform Quality Control (QC) and upload documents to eTMF, ensuring regulatory milestones and timelines are met at country and site levels. - Customize, translate and/or prepare key documents, such...