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AI Summary
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
Learn more about our EEO & Accommodations request here.
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