Clinical Trial Transparency Specialist
1 month ago
At Genmab, we're committed to building extraordinary futures together by developing innovative cancer treatments and pioneering therapies. We believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
Our Clinical Trial Disclosure & Transparency (CTD&T) team plays a crucial role in ensuring successful clinical trial conduct and reporting. We are now expanding our CTD&T team with a Sr. Associate/Manager position.
Job Overview
As a Sr. Associate/Manager in the Clinical Trial Disclosure & Transparency team, you will be responsible for executing global and national clinical trial disclosure requirements across Genmab's entire portfolio. Your key responsibilities include:
- Managing public disclosure of clinical trial protocols, results, and document redaction;
- Developing and maintaining timelines for protocol registration and results disclosure on platforms like ClinicalTrials.gov and EU CTIS;
- Authoring or overseeing plain language results summaries;
- Developing and updating SOPs, templates, and applicable system implementations;
- Training internal staff and vendors on disclosure processes to ensure regulatory compliance;
- Monitoring the external landscape to ensure Genmab's adherence to relevant industry guidelines;
- Managing unsolicited requests via the mailbox.
About You
We are looking for a passionate and innovative colleague who genuinely cares about our mission to transform the lives of patients through innovative cancer treatment. As a strong collaborator, you will work in teams with diverse backgrounds and take pride in enabling the best work of others on the team.
Genmab leverages the effectiveness of an agile working environment, offering a hybrid work arrangement with flexibility. Our offices are designed as open, community-based spaces that connect employees while being immersed in state-of-the-art laboratories.
Estimated salary: $120,000 - $180,000 per year, depending on experience and location. Please note that this estimate is based on industry standards and may vary depending on individual circumstances.
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