Clinical Trial Disclosure Expert
3 days ago
Genmab is a pioneering biotechnology company dedicated to developing innovative antibody products that transform the lives of patients suffering from cancer and serious diseases. Our mission is to build extraordinary futures together by leveraging cutting-edge science and technology to create therapies that make a meaningful difference in people's lives.
The Role
We are seeking an experienced Sr. Associate/Manager to join our Clinical Trial Disclosure & Transparency team. As a key member of this team, you will play a critical role in ensuring the successful conduct and reporting of clinical trials across Genmab's entire portfolio. Your primary responsibilities will include executing global and national clinical trial disclosure requirements, supporting trial teams, and overseeing the relationship with our disclosure vendor(s) to ensure efficiency and compliance.
Key Responsibilities
- Manage public disclosure of clinical trial protocols, results, and document redaction.
- Develop and maintain timelines for protocol registration and results disclosure on platforms like ClinicalTrials.gov and EU CTIS.
- Author or oversee plain language results summaries.
- Develop and update SOPs, templates, and applicable system implementations.
- Train internal staff and vendors on disclosure processes to ensure regulatory compliance.
- Monitor industry guidelines to ensure Genmab's adherence.
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