Regulatory and Start Up Specialist Nordics

2 days ago


Solna Municipality, Sweden IQVIA Argentina Full time

Job Overview

Perform tasks at a country level associated with site activation activities in accordance with local and international regulations, standard operating procedures (SOPs), project requirements, and contractual guidelines. This role involves maintenance activities and requires local language proficiency.

Key Responsibilities

  1. Act as Single Point of Contact (SPOC) for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
  2. Ensure adherence to SOPs, Work Instructions (WIs), quality of designated deliverables, and project timelines.
  3. Perform start-up and site activation activities according to applicable regulations, SOPs, and work instructions.
  4. Prepare site regulatory documents, reviewing for completeness and accuracy.
  5. Maintain accurate internal systems, databases, and tracking tools with project-specific information.
  6. Review and provide feedback on site performance metrics.
  7. Establish and agree on project planning and timelines.
  8. Implement contingency plans as needed.
  9. Inform team members of regulatory document completion for individual sites.
  10. Track and follow up progress, approval, and execution of documents, including release documents, in line with project timelines.
  11. Provide local expertise during initial and ongoing project timeline planning.
  12. Conduct quality control of documents provided by sites.


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