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Regulatory Technician

icon · Barcelona

New
Junior 🇬🇧 English
CTIS Regulatory submissions

Job description

About the role

ICON is a global healthcare intelligence and clinical research organisation. As a Regulatory Technician you will work with the Clinical Trials Information System (CTIS) and support submissions and other documents by carrying out tasks such as assembly and dispatch, and by coordinating resources for submissions.

Key responsibilities

  • Proactively identify and mitigate risks through CTIS helpdesks regarding data and document management and uploads, and liaise with internal and external stakeholders to resolve them.
  • Maintain applicable study-level account access for assigned CTIS projects to ensure compliance and confidentiality.
  • Manage and perform data entry and document upload with key stakeholders.
  • Monitor CTIS and notify stakeholders of activities so they can act and follow up.
  • Create files documenting submissions completed through CTIS, conclusions, decisions and other communications.
  • Perform quality control reviews in line with applicable processes.
  • Maintain agreed timelines and complete project-specific training on time.

Required profile

  • Advanced English (speak, read, write).
  • Ideally 1-2 years of relevant experience in clinical research, or knowledge of clinical terminology and documentation.
  • Ability to work independently.
  • Experience with regulatory submissions and CTIS is a differentiator but not mandatory.
  • Legal right to work in the country where the role is based.

What we offer

  • Competitive base salary and performance-related incentives.
  • Health and wellbeing programmes, including medical, dental and vision coverage where applicable.
  • Retirement and pension plans, life assurance and disability coverage.
  • Employee assistance programmes and wellbeing resources.
  • Learning and development opportunities through structured training and career pathways.

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Published 14 hours ago

Expires 1 month from now

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