Senior Manager, Clinical Trial Disclosure – Transparency

🕒 October 14

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $132.8k - $199.2k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Genmab

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1999

🏥 Healthcare

🧬 Biotechnology

💰 $134M Post-IPO Equity on 2010-06

Healthcare • Biotechnology

Genmab is a biotechnology company focused on transforming lives through pioneering antibody science. The company is dedicated to developing innovative antibody therapeutics for various diseases, aiming to improve patient outcomes and treatment options. Genmab's efforts in antibody research and development highlight its commitment to advancing medical science.

📋 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

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