Regulatory Affairs Specialist for Site Activation

4 days ago


Copenhagen, Copenhagen, Denmark IQVIA LLC Full time
About the Role

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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