Clinical Trial Disclosure Specialist
3 days ago
At Genmab A/S, we are seeking a highly skilled Clinical Trial Disclosure Specialist to join our team. As a key member of our Clinical Trial Disclosure & Transparency team, you will be responsible for executing global and national clinical trial disclosure requirements across our entire portfolio.
Key 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 and other applicable trial registries/platforms.
- Author or 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 and vendors on disclosure processes to ensure regulatory compliance.
- Monitor the external landscape to ensure our adherence to relevant industry guidelines.
- Management of unsolicited requests via our mailbox.
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.
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