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<h2><span class="emphasis-2">Site Navigator II – Denmark (Remote)</span></h2><h2></h2><p>This is a <b>fully remote role based in Denmark</b> where the Site Navigator II plays a key role in coordinating <b>site start-up and regulatory submission activities</b> across clinical studies.</p><p>Acting as the <b>primary point of contact for investigative sites</b>, you will drive progress from feasibility through activation and into maintenance, with a strong focus on <b>regulatory submissions and compliance</b>.</p><p>This role requires <b>hands-on experience with submissions to Regulatory Authorities and IRB/IEC</b>, as well as strong knowledge of <b>ICH-GCP and local regulations</b>. You will operate with limited oversight and act as a <b>local expert and knowledge resource</b> within the team.</p><p></p><h2><span class="emphasis-2"><b>Key Responsibilities</b></span></h2><ul><li>Lead <b>site start-up and activation activities</b> in line with ICH-GCP, regulatory requirements, and study timelines</li><li>Serve as the <b>main contact for investigative sites</b></li><li>Identify, assess, and engage potential sites; manage feasibility and site outreach</li><li>Conduct <b>remote Pre-Study Visits (PSVs)</b> and documentation</li><li>Prepare, submit, and track <b>regulatory and ethics submissions</b> (IRB/IEC, Regulatory Authorities, third bodies)</li><li>Collect, review, and maintain <b>essential regulatory documents</b> through activation and study lifecycle</li><li>Ensure ongoing <b>site compliance</b> (renewals, PI changes, document tracking)</li><li>Support <b>ICF localization and patient-facing materials</b></li><li>Collaborate with GRSL and study teams to ensure <b>submission quality and timelines</b></li><li>Support <b>SIV readiness</b>, vendor coordination, and site setup</li><li>Participate in <b>contract and budget negotiations</b></li><li>Maintain <b>audit-ready TMF</b> and accurate system documentation</li><li>Identify risks, escalate issues, and ensure milestone delivery</li></ul><h2></h2><h2><span class="emphasis-2"><b>Qualifications & Experience</b></span></h2><ul><li>Degree in Life Sciences (or equivalent clinical research experience)</li><li><b>2+ years’ experience in clinical start-up and regulatory processes</b></li><li><b>Hands-on experience with regulatory submissions (essential)</b></li><li>Strong knowledge of <b>ICH-GCP, Regulatory Authorities, and IRB/IEC processes</b></li><li>Experience with <b>site documentation and contract/budget negotiations</b></li><li>Fluent in <b>English and Danish</b></li><li>Strong organisational and stakeholder management skills</li></ul><p></p><p><span>Learn more about our </span><a href="https://careers.fortrea.com/us/en/eeo-and-accommodations" target="_blank" rel="noopener noreferrer">EEO & Accommodations request here</a><span>.</span></p>
