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 through activation and study lifecycle
• Ensure ongoing site compliance (renewals, PI changes, document tracking)
• Support ICF localization and patient-facing materials
• Collaborate with GRSL and study teams to ensure submission quality and timelines
• Support SIV readiness, vendor coordination, and site setup
• Participate in contract and budget negotiations
• Maintain audit-ready TMF and accurate system documentation
• Identify risks, escalate issues, and ensure milestone delivery

Qualifications & Experience

• Degree in Life Sciences (or equivalent clinical research experience)
• 2+ years’ experience in clinical start-up and regulatory processes
• Hands-on experience with regulatory submissions (essential)
• Strong knowledge of ICH-GCP, Regulatory Authorities, and IRB/IEC processes
• Experience with site documentation and contract/budget negotiations
• Fluent in English and Danish
• Strong organisational and stakeholder management skills

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