Clinical Trial Transparency Specialist

1 month ago


Copenhagen, Copenhagen, Denmark Genmab Full time

About the Role:

Genmab is seeking a highly skilled Clinical Trial Transparency Specialist to join its Clinical Trial Disclosure & Transparency (CTD&T) team. This role will be responsible for executing global and national clinical trial disclosure requirements across Genmab's entire portfolio.

Key Responsibilities:

  • Manage, track, and oversee public disclosure of clinical trial protocols, results, and document redaction.
  • Develop and maintain timelines for protocol registration and results disclosure on platforms such as ClinicalTrials.gov and EU CTIS.
  • Author or oversee the development of plain language results summaries.
  • Develop and update SOPs, templates, and oversee applicable system implementations.
  • Train internal staff and vendors on disclosure processes to ensure regulatory compliance.
  • Monitor the external landscape to ensure Genmab's adherence to relevant industry guidelines.
  • Manage unsolicited requests via the mailbox.

Requirements:

  • Previous experience with clinical trial disclosure.
  • Bachelor's degree minimum.
  • 1-3+ years of pharmaceutical industry experience with a good understanding of clinical development.
  • Excellent written and verbal communication skills.

About Genmab:

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics.



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