Senior Manager, Clinical Trial Disclosure Specialist
- Manage, track, and maintain overall responsibility for the 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 in 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 as needed.
- Ensure internal teams are informed of updated or new requirements and laws.
- Ensure management of unsolicited requests received via the [email protected] mailbox.
- 5+ years of clinical trial disclosure experience, including a 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.
- Previous experience as a Medical Writer is advantageous, given the close alignment between the CTD&T and Medical Writing teams.
- Engaged colleague with a positive and collaborative mindset.
- Strong organizational skills; able to manage conflicting priorities.
- High level of integrity, accuracy, and attention to detail.
- Quality mindset with the ability to prioritize in a fast-paced and evolving environment.
- Result- and goal-oriented, committed to contributing to Genmab's success.
- 401(k) Plan: 100% match on the first 6% of contributions
- Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
- Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
- Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
- Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
- Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses
- You are genuinely passionate about our purpose
- You bring precision and excellence to all that you do
- You believe in our rooted-in-science approach to problem-solving
- You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
- You take pride in enabling the best work of others on the team
- You can grapple with the unknown and be innovative
- You have experience working in a fast-growing, dynamic company (or a strong desire to)
- You work hard and are not afraid to have a little fun while you do so!
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