Genmab
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.
Senior Manager, External Data Acquisition, Clinical Data Management
Job not on LinkedIn
November 27
Genmab
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
• 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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