Manager, Clinical Trial Disclosure
4 maanden geleden
The Role
& DepartmentGenmab is committed to transparency of clinical trial research. We recognize the scientific and ethical value of sharing clinical trial information in a non-biased and timely manner to benefit patients and other external stakeholders. The Clinical Trial Disclosure & Transparency (CTD&T) team resides within Development Operations, which hosts key functions for ensuring successful conduct and reporting of clinical trials.
We are now expanding our CTD&T team with a Manager position. Besides interesting and developing tasks, you will get a unique opportunity to join a collaborative team of passionate and innovative colleagues.
In the role as Manager, Clinical Trial Disclosure & Transparency, you will be executing against global and national clinical trial disclosure requirements across the entire Genmab portfolio. Key responsibilities include supporting trial teams and applicable functions to ensure high-quality output and responsible disclosure of clinical trial information. Further, your responsibility includes implementation of new transparency requirements and training of staff. You will also oversee the relationship between Genmab and our disclosure vendor(s) to ensure efficiency and compliance.
Key responsibilities include
Manage, track, and maintain overall responsibility for public disclosure of clinical trial protocols, results, and redaction of documents.
Develop and maintain timelines for authoring of protocol registration and results disclosure activities on ClinicalTrials.gov, EU CTIS and other applicable trial registries/platforms. Work in close collaboration with disclosure vendor(s), if applicable.
Author/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/vendors on applicable disclosure processes to ensure regulatory compliance.
Monitor the external landscape to ensure Genmab’s adherence to relevant industry guidelines.
Management of unsolicited requests via the
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