Senior Manager, External Data Acquisition, Clinical Data Management

Genmab • Plainsboro Township, NJ

27d

About The Position

As a Senior Manager in External Data Acquisition, you will play a pivotal role within our Clinical Data Management team. Your primary responsibility will be to oversee the acquisition and integration of third-party data (e.g., laboratories, eCOA providers, technology providers, etc.) who perform testing or data collection services on behalf of Genmab, ensuring its alignment with clinical trials' objectives and regulatory standards.

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.

Responsibilities

• Lead and provide strategic insights into protocol development, specifically 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, facilitating efficient data analysis and reporting.
• Develop detailed data transfer specifications for acquiring external data from third-party vendors.
• Coordinate with vendors to guarantee that 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 (Biomarker Operations, Data Management, Data Analytics, Medical, Statistics, etc.) and external partners to ensure adherence to Genmab’s requirements and timelines.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 1,001-5,000 employees