Clinical Research Operations Specialist

1 week ago


Stockholm, Stockholm, Sweden IQVIA Argentina Full time

About the Role

This position plays a critical role in conducting end-to-end site start-up, from feasibility to closure. As the primary point of contact for the site, country, and study team, you will support site-level feasibility assessments, coordinate site identification at a country and regional level, and oversee site qualification and start-up activities.

Key Responsibilities

  • Participate in study-specific site management meetings to ensure seamless coordination among team members.
  • Utilize tools to track activities and develop reports that provide valuable insights into site performance.
  • Responsible for essential document collection, tracking, and review to ensure compliance with regulatory requirements.
  • Collect and analyze country and site-level intelligence to inform strategic decisions.
  • Prepare and submit Institutional Review Board/Ethics Committee documents for the country.
  • Support Regulatory Authority submissions and manage site-level Regulatory Green Light processing.
  • May serve as an In-House Study Lead on limited-scope studies, providing guidance and oversight to the study team.

Requirements

  • Preferred BA/BS degree in Business Administration, science, or related field, or additional relevant experience.
  • Thorough understanding of clinical research principles and processes.
  • Comprehensive knowledge of FDA and/or EU Directives and Regulations, ICH Guidelines, and various country/local regulatory requirements.


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