Site Navigator - Denmark

Financial Planning and AnalysisFinancial Planning and AnalysisFull TimeRemoteMid LevelTeam 10,001+H1B No SponsorCompany SiteLinkedIn

Location

Denmark

Posted

60 days ago

Salary

0

Seniority

Mid Level

No structured requirement data.

Job Description

Site Navigator - Denmark

Fortrea

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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