Clinical Trial Transparency Specialist

2 days ago

Copenhagen, Copenhagen, Denmark Genmab AS Full time

We are seeking a highly skilled Clinical Trial Transparency Specialist to join our team at Genmab A/S. This is an exciting opportunity for someone who wants to be part of a dynamic company and contribute to improving the lives of patients with cancer.

About the Role

The successful candidate will be responsible for executing global and national clinical trial disclosure requirements across our entire portfolio. Key responsibilities include supporting trial teams, ensuring high-quality disclosure of clinical trial information, implementing new transparency requirements, and overseeing relationships with disclosure vendors to ensure efficiency and compliance.

Responsibilities
  • Manage, track, and oversee public disclosure of clinical trial protocols, results, and document redaction.
  • Develop and maintain timelines for protocol registration and results disclosure on platforms such as ClinicalTrials.gov and EU CTIS, as well as other applicable trial registries/platforms.
  • Author or oversee the development of plain language results summaries.
  • Develop and update standard operating procedures (SOPs), templates, and oversee system implementations, assessing technology/AI needs and managing implementation of required software.
  • Train internal staff and vendors on disclosure processes to ensure regulatory compliance.
  • Monitor the external landscape to ensure adherence to relevant industry guidelines.
  • Manage unsolicited requests via the mailbox.
Requirements
  • Previous experience in clinical trial disclosure.
  • Bachelor's degree minimum.
  • 1-3+ years of pharmaceutical industry experience with a good understanding of clinical development.
  • Excellent written and verbal communication skills.
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 A/S.
Salary

We offer a competitive salary ranging from $80,000 to $110,000 per annum, depending on qualifications and experience.

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