Senior Manager, Clinical Trial Disclosure & Transparency
Genmab
Genmab seeks a Senior Manager for Clinical Trial Disclosure & Transparency to oversee global and national disclosure regulations across its clinical trial portfolio. The role combines operational and strategic responsibilities, managing trial protocol and results submissions to registries while ensuring compliance and cross-functional collaboration.
Responsibilities
- Manage clinical trial protocol and results submissions to ClinicalTrials.gov, EU CTIS, and other registries
- Oversee redaction activities and development of plain language results summaries
- Monitor industry guidelines and update standard operating procedures for compliance
- Supervise vendor performance and coordinate with clinical CROs on consistent messaging
- Deliver training on disclosure processes to internal staff, CROs, and vendors; manage unsolicited information requests
Requirements
- 5+ years of clinical trial disclosure experience
- Bachelor's or Master's degree in relevant field
- Strong knowledge of disclosure requirements, technology, and platforms
- Expertise in regulatory processes and compliance frameworks
- Excellent organizational and communication skills
- Experience managing vendor and CRO relationships
Vacancy posted 16 days ago
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