Job summary
This full-time, permanent remote role involves coordinating clinical trial site start-up activities across multiple Nordic countries, including Norway. The specialist manages regulatory documentation and submissions to ensure compliance with ICH/GCP guidelines and local requirements, supporting effective site activation and maintenance. Fluency in Norwegian, Swedish, Finnish, and English is necessary due to region coverage.
Location and work setup
- Location
- Norway
- Work setup
- Remote
Responsibilities
Serve as the main liaison for investigative sites during start-up and ongoing activities; collect, review, and organize essential regulatory documents; prepare and submit country-specific regulatory applications including informed consent forms; monitor submission timelines and address delays; collaborate with internal teams, vendors, and regulatory authorities; ensure audit-ready documentation and updated systems; support site contract and budget negotiations; mentor and train junior colleagues.
Qualifications
A university degree in life sciences or related allied health profession or equivalent relevant experience; minimum two years’ experience in clinical research, regulatory submissions, or site activation; thorough knowledge of ICH/GCP, regulatory authority requirements, and start-up processes; demonstrated ability to adapt informed consent documents to local and protocol-specific needs; experience working with regulatory authorities and clinical site teams; strong organizational, problem-solving, and communication skills; proficiency with Microsoft Office and document management systems; fluency in Norwegian, Swedish, Finnish, and English.