Senior Manager, Clinical Trial Disclosure – Transparency

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Oversee, track, and maintain the overall responsibility for the disclosure of clinical trial protocols and results on ClinicalTrials.gov, EU CTIS, and other relevant registries/platforms.

• Provide support and guidance regarding redaction activities.

• Ensure the creation of plain language summaries of results.

• Stay informed about industry guidelines to guarantee compliance.

• Assist in updating Standard Operating Procedures (SOPs), contribute to process enhancements, and uphold adherence to established standards.

• Supervise vendor performance concerning transparency deliverables.

• Collaborate with clinical Contract Research Organizations (CROs) to ensure consistent messaging in study registries.

• Conduct training on Genmab's disclosure processes for internal staff and offer guidance to CROs and vendors.

• Keep internal teams updated on new or revised requirements and regulations.

• Manage unsolicited inquiries received via the clinicaltrials@genmab.com email address.

⛳️ Requirements

• A minimum of 5 years of experience in clinical trial disclosure.

• Bachelor's or Master's degree in a relevant field.

• Strong understanding of disclosure requirements, technologies, and platforms.

• Demonstrated ability to lead projects and facilitate collaboration across functions.

• Exceptional written and verbal communication skills that are effective, respectful, and succinct.

• Previous experience as a Medical Writer is a plus.

🏝️ Benefits

• 401(k) Plan: 100% match on the first 6% of contributions.

• Two medical plan options (including HDHP with HSA), as well as dental and vision insurance.

• Critical illness, accident, and hospital indemnity insurance.

• Paid vacation, sick leave, and holidays.

• 12 weeks of discretionary paid parental leave.

• Access to child and adult backup care.

• Family support programs.

• Financial wellness tools.

• Emotional well-being support.

• Commuter benefits.

• Tuition reimbursement.

• Lifestyle Spending Account for wellness and personal expenses.

• Discretionary bonuses and long-term incentives may be available for eligible positions.