Clinical Trial Disclosure Manager

2 months ago

Copenhagen, Copenhagen, Denmark Genmab Full time
About the Role

Genmab is seeking a highly skilled and experienced professional to join our Clinical Trial Disclosure & Transparency team as a Manager. This role will be responsible for executing against global and national clinical trial disclosure requirements across our entire portfolio.

Key Responsibilities
  • Manage, track, and maintain overall responsibility for public disclosure of clinical trial protocols, results, and redaction of documents.
  • Develop and maintain timelines for authoring of protocol registration and results disclosure activities on, EU CTIS and other applicable trial registries/platforms.
  • Author/oversee the development of plain language results summaries.
  • Develop and update SOPs, templates, and oversee applicable system implementations.
  • Train internal staff/vendors on applicable disclosure processes to ensure regulatory compliance.
  • Monitor the external landscape to ensure Genmab's adherence to relevant industry guidelines.
  • Management of unsolicited requests via the mailbox.
  • Being a great representative for Development Operations on inter and intra-departmental initiatives.
Requirements
  • A minimum of a bachelor's degree.
  • 5+ years of pharmaceutical industry experience with good understanding of clinical development.
  • Excellent written and verbal communication skills.
  • Previous experience with clinical trial disclosure is strongly preferred.
About You
  • You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment.
  • You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving.
  • You are a generous collaborator who can work in teams with diverse backgrounds.
  • You are determined to do and be your best and take pride in enabling the best work of others on the team.
  • You are not afraid to grapple with the unknown and be innovative.
  • You have experience working in a fast-growing, dynamic company (or a strong desire to).
  • You work hard and are not afraid to have a little fun while you do so.

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