Project Lead for Clinical Trial Submissions

1 week ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

Clinical Trial Submission Job Description

This is a unique opportunity to join our CTA Management department as a Clinical Trial Submission Manager. In this role, you will lead the submission of initial Clinical Trial Applications (CTAs) and amendments to Health Authorities (HAs) and Ethics Committees (ECs). You will collaborate closely with stakeholders across Development and Affiliate to ensure timely and compliant submissions on a global scale.

  • Develop and implement efficient CTA submission processes to meet business needs and priorities.
  • Ensure CTA submission adheres to all applicable regulatory requirements worldwide, driving consistency and best practices across trials.
  • Oversee the preparation and monitoring of CTA documents for submission of initial CTAs and amendments.
  • Support the team in analyzing and resolving CTA-related issues.
  • Contribute to CTA process and system improvements to enhance efficiency and effectiveness.

Key Performance Indicators

  • Timely submission of CTAs and amendments.
  • Compliance with all applicable regulatory requirements worldwide.
  • Efficient CTA document preparation and monitoring.
  • Effective collaboration with cross-functional teams and stakeholders.


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