Site Navigator - Denmark

Job description

Site Navigator II – Denmark (Remote) This is a fully remote role based in Denmark where the Site Navigator II plays a key role in coordinating site start-up and regulatory submission activities across clinical studies. Acting as the primary point of contact for investigative sites , you will drive progress from feasibility through activation and into maintenance, with a strong focus on regulatory submissions and compliance . This role requires hands-on experience with submissions to Regulatory Authorities and IRB/IEC , as well as strong knowledge of ICH-GCP and local regulations . You will operate with limited oversight and act as a local expert and knowledge resource within the team. Key Responsibilities: - Lead site start-up and activation activities in line with ICH-GCP, regulatory requirements, and study timelines - Serve as the main contact for investigative sites - Identify, assess, and engage potential sites; manage feasibility and site outreach - Conduct remote Pre-Study Visits (PSVs) and documentation - Prepare, submit, and track regulatory and ethics submissions (IRB/IEC, Regulatory Authorities, third bodies) - Collect, review, and maintain essential regulatory documents...