Manager, Clinical Trial Disclosure

1 week geleden

Utrecht, Utrecht, Nederland Genmab Voltijd

The Role

& Department

Genmab is committed to transparency of clinical trial research. We recognize the scientific and ethical value of sharing clinical trial information in a non-biased and timely manner to benefit patients and other external stakeholders. The Clinical Trial Disclosure & Transparency (CTD&T) team resides within Development Operations, which hosts key functions for ensuring successful conduct and reporting of clinical trials.

We are now expanding our CTD&T team with a Manager position. Besides interesting and developing tasks, you will get a unique opportunity to join a collaborative team of passionate and innovative colleagues.

In the role as Manager, Clinical Trial Disclosure & Transparency, you will be executing against global and national clinical trial disclosure requirements across the entire Genmab portfolio. Key responsibilities include supporting trial teams and applicable functions to ensure high-quality output and responsible disclosure of clinical trial information. Further, your responsibility includes implementation of new transparency requirements and training of staff. You will also oversee the relationship between Genmab and our disclosure vendor(s) to ensure efficiency and compliance.

Key responsibilities include

  • 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. Work in close collaboration with disclosure vendor(s), if applicable.
  • Author/oversee the development of plain language results summaries.
  • Develop and update SOPs, templates, and oversee applicable system implementations. Assess technology/AI needs and manage implementation of required software.
  • 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.

Moreover, you meet the following personal requirements:

  • Engaged colleague with a positive and collaborative mindset.
  • Goal- and improvement-oriented with proven track record of deliveries against set timelines.
  • Strong organizational skills with ability to plan and prioritize tasks.
  • Proven ability to work with a high level of integrity, accuracy, and attention to details.
  • Committed to contributing to the overall success of Genmab.

This role can be located in Copenhagen DK, or Utrecht NL and is hybrid.

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

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

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