
Clinical Research Specialist Regulatory Nordics
1 day ago
Job Description
This role involves performing site activation activities at a country level, ensuring compliance with local and international regulations, standard operating procedures (SOPs), project requirements, and contractual guidelines. The ideal candidate will possess strong analytical and problem-solving skills and be proficient in the local language.
Key Responsibilities
- Act as SPOC for investigative sites, SAM, and other departments as necessary.
- Prepare site regulatory documents and perform start-up activities.
- Ensure compliance with SOPs, WIs, and quality standards.
- Maintain accurate internal systems and tracking tools.
- Collaborate with the Project Management team to establish project planning and timelines.
- Implement contingency plans as needed.
- Inform team members of completed regulatory documents for individual sites.
- Track and follow up progress, approval, and execution of documents in line with project timelines.
- Offer local expertise during project planning and implementation.
Essential Qualifications
At least 1 year of clinical research experience is required.
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