Senior Manager, External Data Acquisition, Clinical Data Management
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 Apply tot his job