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Clinical Trial Disclosure Manager

2 maanden geleden

Utrecht, Utrecht, Nederland Genmab Voltijd
About the Role

Genmab is seeking a highly skilled and experienced Manager to join our Clinical Trial Disclosure & Transparency team. As a key member of our Development Operations team, you will play a critical role in ensuring the transparency and disclosure of clinical trial information across our global portfolio.

Key Responsibilities
  • Public Disclosure Management: Oversee the public disclosure of clinical trial protocols, results, and redacted documents, ensuring compliance with global and national requirements.
  • Timelines and Collaboration: Develop and maintain timelines for authoring protocol registration and results disclosure activities on various trial registries and platforms, working closely with disclosure vendors.
  • Results Summaries: Author and oversee the development of plain language results summaries, ensuring clarity and accuracy.
  • SOPs and Templates: Develop and update Standard Operating Procedures (SOPs), templates, and oversee system implementations to ensure efficient and compliant disclosure processes.
  • Training and Compliance: Train internal staff and vendors on applicable disclosure processes to ensure regulatory compliance and adherence to industry guidelines.
  • Industry Landscape Monitoring: Monitor the external landscape to ensure Genmab's adherence to relevant industry guidelines and best practices.
  • Representative Role: Serve as a representative for Development Operations on inter and intra-departmental initiatives, fostering collaboration and communication.
Requirements
  • Education: A minimum of a bachelor's degree.
  • Experience: 5+ years of pharmaceutical industry experience with a good understanding of clinical development.
  • Communication Skills: Excellent written and verbal communication skills.
  • Preferred Experience: Previous experience with clinical trial disclosure is strongly preferred.
About You
  • You are passionate about Genmab's 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, and 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.