Key Facts

Remote From:

Full time

Mid-level (2-5 years)

Danish, English

Hard Skills

Electronic Trial Master File IEC 61508 Standard Regulatory Compliance IEC 61508 Standard Regulatory Compliance Regulatory Compliance Regulatory Compliance Contract Management Software Documentation Site Assessment +7 more

Other Skills

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Organizational Skills

Roles & Responsibilities

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) and strong knowledge of ICH-GCP, Regulatory Authorities, and IRB/IEC processes
Fluent in English and Danish

Requirements:

Lead site start-up and activation activities in line with ICH-GCP, regulatory requirements, and study timelines
Prepare, submit, and track regulatory and ethics submissions (IRB/IEC, Regulatory Authorities, third bodies) and maintain essential regulatory documents through activation and lifecycle
Maintain ongoing site compliance (renewals, PI changes, document tracking) and ensure audit-ready TMF and accurate system documentation
Collaborate with study teams to ensure submission quality and timelines, support SIV readiness, vendor coordination, site setup, and assist in contract and budget negotiations

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