Senior Manager, Clinical Trial Disclosure – Transparency

🔥 4 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $132.8k - $199.2k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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Genmab

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Genmab is a biotechnology company focused on pioneering antibody science to transform patient lives. The company develops therapeutic antibodies and antibody-based technologies for treating cancer and other diseases, emphasizing innovative antibody engineering and immunotherapy approaches. Genmab partners with other biopharma companies to advance clinical-stage and commercial antibody medicines.

📋 Description

• Manage, track, and maintain overall responsibility for disclosure of clinical trial protocols and results on ClinicalTrials.gov, EU CTIS, and other applicable registries/platforms • Support and provide guidance on redaction activities • Ensure development of plain language results summaries • Stay updated on industry guidelines to ensure compliance • Support updating SOPs, contribute to process improvements, and maintain adherence to established standards • Oversee vendor performance related to transparency deliverables • Liaise with clinical CROs to ensure consistent messaging across study registries • Deliver training on Genmab's disclosure processes to internal staff and provide guidance to CROs and vendors • Ensure internal teams are informed of updated or new requirements and laws • Manage unsolicited requests received via the [email protected] mailbox

🎯 Requirements

• 5+ years of clinical trial disclosure experience • Bachelor's or Master's degree with relevant specialization • Strong knowledge of disclosure requirements, technology, and platforms • Proven ability to lead projects and facilitate cross-functional collaboration • Excellent written and verbal communication that is effective, respectful, and concise • Previous experience as a Medical Writer is advantageous

🏖️ Benefits

• 401(k) Plan: 100% match on the first 6% of contributions • Two medical plan options (including HDHP with HSA), 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