Clinical Trial Disclosure Manager

2 maanden 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 stakeholders alike. The Clinical Trial Disclosure & Transparency (CTD&T) team is an integral part of our Development Operations, which encompasses essential functions for the successful execution and reporting of clinical trials.

We are expanding our CTD&T team and are looking for a Manager to take on this pivotal role. This position offers engaging and evolving responsibilities, as well as the chance to collaborate with a team of dedicated and innovative professionals.

Key Responsibilities

  • Oversee and ensure the public disclosure of clinical trial protocols, results, and document redactions.
  • Create and manage timelines for protocol registration and results disclosure activities on relevant trial registries/platforms, collaborating closely with disclosure vendors as necessary.
  • Author and supervise the creation of accessible results summaries.
  • Develop and revise standard operating procedures (SOPs), templates, and manage the implementation of necessary systems and technologies.
  • Provide training to internal staff and vendors on disclosure processes to ensure compliance with regulations.
  • Stay informed on industry guidelines to ensure Genmab's adherence to best practices.
  • Manage unsolicited requests through the designated communication channels.
  • Represent Development Operations effectively in interdepartmental initiatives.

Qualifications

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

Personal Attributes

  • A collaborative team player with a positive attitude.
  • Results-driven and focused on continuous improvement with a proven track record of meeting deadlines.
  • Strong organizational skills with the ability to prioritize effectively.
  • A commitment to integrity, accuracy, and attention to detail.
  • Dedicated to contributing to Genmab's overall success.

Work Environment

This role supports a hybrid working model, allowing for flexibility in your work environment. Genmab fosters an agile working atmosphere that enhances employee work-life balance. Our offices are designed to promote collaboration and innovation among employees, whether in our community-oriented spaces or while working remotely.

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