Job Description:
• Oversee the acquisition and integration of third-party data (e.g., laboratories, eCOA providers, technology providers)
• Lead and provide strategic insights into protocol development, focusing on external data collection and integration
• Standardize data type specifications to align with Electronic Data Capture (EDC) requirements and clinical trial objectives
• Ensure that data transfer processes comply with CDASH and SDTM standards
• Develop detailed data transfer specifications for acquiring external data from third-party vendors
• Coordinate with vendors to guarantee data collection is compatible with clinical databases and meets SDTM requirements
• Oversee Data Management Contract Research Organizations (DM CROs) for seamless external data transfers
• Review and assess vendor contracts, setup specifications, and test data transfers
• Proactively identify and resolve issues related to external data transfers throughout the trial lifecycle
• Collaborate with internal teams and external partners to ensure adherence to Genmab’s requirements and timelines
Requirements:
• Bachelor's degree in science or a related field
• 5-8+ years of experience in clinical data management with a focus on external data in the biotech/pharma industry
• Profound knowledge of oncology trials, EDC systems, and technical aspects of data transfer
• Strong understanding of data management processes, tools, methodologies, and documentation
• Familiarity with GCPs, SOPs, regulatory requirements, and good data management practices
• Proficiency in CDISC (SDTM) standards and clinical data standards development
• Proven project management skills
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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