Senior Clinical Data Manager
Data ScientistData ScientistFull TimeRemoteTeam 1,001-5,000Since 1999H1B SponsorCompany SiteLinkedIn
Location
New Jersey
Posted
16 days ago
Salary
$133.0K - $199.6K / year
Bachelor Degree8 yrs expEnglishGoogle Cloud Platform
Job Description
• Operationally responsible for the planning, start-up, conduct and closure of clinical trials
• Provide oversight of the DM CRO and ensure performance against key indicators
• Support/training colleagues in handling data management related processes/issues and mentoring
• Participate in and drive implementation of lessons learned and new procedures to ensure high standards/improvement
• Ensure compliance with relevant regulations, Genmab SOPs and ICH GCP
• Perform vendor oversight related to key deliverables
• Give input to the clinical development plans through the Development Operations representatives
• Support vendor qualification in terms of Data management, ePRO and IRT related activities
Job Requirements
- Bachelor's degree in science or related area (or equivalent)
- Minimum of 8 years of experience in clinical data management
- Strong understanding of end-to-end trial conduct
- Strong Project Management capability
- Strategic planning and portfolio thinking
- Operational excellence and process improvement mindset
- Cross-functional alignment and communication
- Vendor oversight and partnership management
- Problem solving, critical thinking and decision making
- Knowledge of EDC systems, ICH-GCP, GDMP, and regulatory expectations
- Experience in oncology preferred.
Benefits
- 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
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