Clinical Trial Transparency Specialist
1 month ago
About the Role:
Genmab is seeking a highly skilled Clinical Trial Transparency Specialist to join its Clinical Trial Disclosure & Transparency (CTD&T) team. This role will be responsible for executing global and national clinical trial disclosure requirements across Genmab's 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.
- Author or oversee the development of plain language results summaries.
- Develop and update SOPs, templates, and oversee applicable system implementations.
- Train internal staff and vendors on disclosure processes to ensure regulatory compliance.
- Monitor the external landscape to ensure Genmab's adherence to relevant industry guidelines.
- Manage unsolicited requests via the mailbox.
Requirements:
- Previous experience with 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.
About Genmab:
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics.
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