Senior Manager, Clinical Trial Transparency & Disclosure

BioNJ Inc.; New Jersey; Remote; USD 133,000 - 199,000; Full time

Benefits offered by this job

401(k) match

Health benefits

Voluntary plans

Paid time off

Support resources

Lifestyle Spending Account

Job summary

Genmab is seeking a Senior Manager for CTD&T to drive disclosure across a global portfolio. You will work with internal teams and external CROs to ensure compliant and transparent reporting of trials, develop plain language summaries, and maintain adherence to evolving regulations.

You will manage registries, oversee vendors, and train staff on disclosure processes, while staying current with industry guidelines and SOP updates in a collaborative, high-impact environment.

Qualifications

• 5+ years of clinical trial disclosure experience with a relevant degree
• Strong knowledge of disclosure requirements, technology, and platforms
• Proven ability to lead projects and collaborate cross-functionally
• Excellent written and verbal communication that is concise and respectful
• Medical writing experience is advantageous and beneficial

Responsibilities

• Manage disclosure of clinical trial protocols and results on ClinicalTrials.gov, EU CTIS, and other platforms
• Guide redaction activities as needed
• Develop plain language results summaries
• Stay updated on industry guidelines and compliance
• Update SOPs and drive process improvements
• Oversee vendor performance related to transparency deliverables
• Coordinate with CROs to ensure consistent messaging
• Deliver training on disclosure processes to internal staff and CROs
• Inform teams of updated requirements and laws
• Handle unsolicited requests via the designated mailbox

Skills

Clinical trial disclosure experience

Regulatory knowledge

Project leadership

Excellent communication

Medical writing experience

Education

Bachelor's or Master's in relevant field

Job description

Genmab is seeking a Senior Manager for CTD&T to drive disclosure across a global portfolio. You will work with internal teams and external CROs to ensure compliant and transparent reporting of trials, develop plain language summaries, and maintain adherence to evolving regulations.

You will manage registries, oversee vendors, and train staff on disclosure processes, while staying current with industry guidelines and SOP updates in a collaborative, high-impact environment.