Clinical Trial Disclosure Manager

5 dagen geleden

Utrecht, Utrecht, Nederland Genmab Voltijd

Position Overview

At Genmab, we prioritize the transparency of clinical research. We understand the importance of sharing clinical trial data in a timely and unbiased manner to benefit patients and other stakeholders. The Clinical Trial Disclosure & Transparency (CTD&T) team operates within Development Operations, which encompasses essential functions for the effective management and reporting of clinical trials.

We are currently enhancing our CTD&T team with a managerial role. This position offers engaging and progressive responsibilities, along with a unique chance to collaborate with a team of dedicated and innovative professionals.

Key Responsibilities

  • Oversee, monitor, and maintain the public disclosure of clinical trial protocols, results, and document redactions.
  • Create and manage timelines for the preparation of protocol registrations and results disclosures on various trial registries and platforms, collaborating closely with disclosure vendors as necessary.
  • Lead the development of clear and accessible results summaries.
  • Formulate and revise standard operating procedures (SOPs), templates, and manage the implementation of relevant systems. Evaluate technology and AI requirements and oversee the deployment of necessary software.
  • Educate internal staff and vendors on relevant disclosure processes to ensure compliance with regulations.
  • Stay informed about the external landscape to guarantee Genmab's adherence to pertinent industry standards.
  • Manage unsolicited inquiries through the designated communication channels.
  • Represent Development Operations effectively in both inter-departmental and intra-departmental initiatives.

Qualifications

  • A minimum of a bachelor’s degree.
  • At least 5 years of experience in the pharmaceutical sector with a solid understanding of clinical development.
  • Exceptional written and verbal communication abilities.
  • Prior experience in clinical trial disclosure is highly desirable.

Personal Attributes

  • A proactive team member with a positive and collaborative attitude.
  • Results-oriented and focused on continuous improvement, with a proven history of meeting deadlines.
  • Strong organizational capabilities with the ability to prioritize and manage tasks effectively.
  • Demonstrated integrity, accuracy, and attention to detail.
  • Committed to contributing to Genmab's overall success.

About You

  • You are passionate about our mission to transform patient lives through innovative cancer therapies.
  • You bring rigor and excellence to your work, believing in a science-based approach to problem-solving.
  • You are a collaborative individual who thrives in diverse teams.
  • You are dedicated to achieving your best and supporting the success of your colleagues.
  • You embrace challenges and are open to innovative solutions.
  • You have experience in a dynamic, fast-paced environment or a strong desire to work in one.
  • You are hardworking and enjoy your work.

Work Environment

Genmab promotes an agile working environment to enhance employee work-life balance. Our offices are designed as open, community-oriented spaces that foster connections among employees while utilizing our state-of-the-art laboratories. Whether working in our collaborative office spaces or remotely, we prioritize connection and innovation.

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