Associate Director, External Data Quality Manager

Genmab • Lincoln, NE

1d

About The Position

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! The Role The Associate Director, External Data Quality Management, is a strategic leadership role supporting high-quality execution of Genmab’s clinical trial portfolio. This individual is accountable for driving the strategy, quality, and integrity of external data across the clinical programs. The Associate Director will guide cross‑functional teams, oversee external data quality and vendor performance, as well as champion harmonized operational approaches that strengthen trial delivery, inspection readiness, and decision‑making.

Requirements

• Bachelor’s degree in a scientific, technical, or health-related field; advanced degree (MS, PhD) preferred.
• Minimum of 10 years of experience in clinical operations, clinical data management, or other related clinical research experience with at least 3–5 years in oversight and leadership roles.
• 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

Nice To Haves

• Experience in oncology preferred.

Responsibilities

• Portfolio and Strategic Leadership Serve as a portfolio‑level lead for external data quality and clinical data‑related operational strategy. Drive consistency of processes, quality expectations, and documentation across studies, assets, and vendors. Solve complex operational issues by gathering detailed inputs, synthesizing technical and business considerations, formulating data-driven recommendations, securing cross-functional alignment, and leading effective implementation. Influence portfolio‑level decision making by providing strategic insights on risks, timelines, and data‑dependent operational impacts. Contribute to asset‑level planning, governance forums, and clinical development strategy discussions.
• External Data Quality Oversight Oversee portfolio‑level strategy for acquisition, integration, and quality oversight of third‑party data (e.g., central/local labs, eCOA, imaging, biomarkers). Provide expert review of protocol requirements, vendor specifications, and operational data flows. Lead proactive data quality surveillance and escalation management.
• Cross-functional Collaboration Collaborate with Trial Management, Medical, Biomarker Operations, Clinical Programming, Biostatistics, and Medical Writing to ensure aligned execution and issue resolution. Ensure operational readiness and cross‑functional understanding of external data processes, timelines, and deliverables. Participate in governance forums and asset-level data planning initiatives.
• Process Excellence and Standardization Drive continuous improvement initiatives that enhance efficiency, consistency, and inspection readiness across Clinical Operations and Clinical Data Management. Lead the development, implementation, and governance of standardized processes, playbooks, RACI models, and best practices. Identify operational bottlenecks and deliver scalable solutions at portfolio level.
• Vendor and Partnership Oversight Provide strategic oversight of external vendors handling clinical data; focus on operational performance, quality compliance, and cross‑trial consistency. Represent External Data Quality Management on Operational Committees with CROs or external data vendors.
• Regulatory and Submission Support Contribute to regulatory submission strategy, ensuring external data and associated processes meet inspection and documentation requirements. Provide asset‑level oversight of data‑related deliverables for submissions.
• Drive alignment meetings within the data management group to ensure consistency of data management practices across trials within an asset and/or within the trials conducted by a DM vendor/partner
• Contribute to the development of best practices/SOPs within Genmab Clinical Data Management, aligned with industry and regulatory best practices
• Provide subject matter expertise to various task forces and initiatives
• Act as Portfolio Asset External Data Quality Management Lead as required.
• Mentor and develop new team members

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: Director
• Number of Employees: 1,001-5,000 employees