Clinical Trial Disclosure Manager

2 maanden geleden

Utrecht, Utrecht, Nederland Genmab Voltijd

Position Overview

At Genmab, we are dedicated to the transparent dissemination of clinical trial information. We understand the critical importance of sharing clinical trial data in a timely and unbiased manner to enhance patient outcomes and support external stakeholders. The Clinical Trial Disclosure & Transparency (CTD&T) team is an integral part of our Development Operations, which encompasses essential functions to ensure the effective execution and reporting of clinical trials.

We are currently looking to expand our CTD&T team by adding a Manager role. This position offers engaging and developmental responsibilities, along with the chance to collaborate with a team of dedicated and innovative professionals.

Key Responsibilities

  • Oversee and manage the public disclosure of clinical trial protocols, results, and document redactions.
  • Create and maintain timelines for protocol registration and results disclosure activities on various trial registries/platforms, collaborating closely with disclosure vendors as necessary.
  • Lead the creation of plain language summaries of results.
  • Develop and revise standard operating procedures (SOPs), templates, and manage the implementation of relevant systems, including assessing technology and AI needs.
  • Provide training to internal staff and vendors on disclosure processes to ensure compliance with regulations.
  • Monitor the external environment to ensure adherence to industry guidelines.
  • Manage unsolicited requests through designated communication channels.
  • Act as a representative for Development Operations in inter-departmental initiatives.

Qualifications

  • A bachelor’s degree or higher.
  • At least 5 years of experience in the pharmaceutical industry with a solid understanding of clinical development.
  • Exceptional written and verbal communication skills.
  • Previous experience in clinical trial disclosure is highly preferred.

Personal Attributes

  • A collaborative colleague with a positive and engaging mindset.
  • Goal-oriented and focused on continuous improvement, with a proven track record of meeting deadlines.
  • Strong organizational abilities with a knack for planning and prioritizing tasks.
  • Demonstrated integrity, accuracy, and attention to detail.
  • Committed to contributing to the overall success of Genmab.

Work Environment

This position supports a hybrid work model, allowing flexibility in work arrangements.

About You

  • You are passionate about our mission to transform patient lives through innovative cancer therapies.
  • You bring a rigorous approach to your work and believe in a science-based methodology for problem-solving.
  • You excel in collaborative environments and can work effectively with diverse teams.
  • You are dedicated to achieving excellence and empowering your colleagues to perform at their best.
  • You embrace challenges and are open to innovative solutions.
  • You thrive in dynamic, fast-paced settings.
  • You are hardworking and enjoy fostering a positive work atmosphere.

Company Culture

Genmab promotes an agile working environment to enhance employee work-life balance. Our office spaces are designed to foster community and collaboration while being equipped with state-of-the-art laboratories. Whether working in our collaborative office spaces or remotely, we prioritize connection and innovation.

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