Regulatory Affairs Specialist for Site Activation
4 days ago
This is an exciting opportunity to join our team as a Regulatory Affairs Specialist for Site Activation in the Nordics region.
You will be responsible for performing tasks at a country level associated with Site Activation (SA) activities, ensuring adherence to local and international regulations, standard operating procedures (SOPs), project requirements, and contractual guidelines.
This is a home-based role that requires proficiency in the local language.
Key Responsibilities:
- Serve as Single Point of Contact (SPOC) for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments.
- Ensure adherence to SOPs, Work Instructions (WIs), quality of designated deliverables, and project timelines.
- Perform start-up and site activation activities according to applicable regulations, SOPs, and work instructions.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Ensure accurate completion and maintenance of internal systems, databases, and tracking tools.
- Review and provide feedback to management on site performance metrics.
Qualifications:
- At least 1 year of clinical research experience.
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