Associate Director, External Data Quality Manager
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Job Description
Associate Director overseeing external data quality management for clinical trials at Genmab. Driving strategy, quality, and integrity of external data across clinical programs while collaborating cross-functionally.
Responsibilities:
- 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.
- 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.
- Collaborate with Trial Management, Medical, Biomarker Operations, Clinical Programming, Biostatistics, and Medical Writing to ensure aligned execution and issue resolution.
- Drive continuous improvement initiatives that enhance efficiency, consistency, and inspection readiness across Clinical Operations and Clinical Data Management.
- Provide strategic oversight of external vendors handling clinical data; focus on operational performance, quality compliance, and cross‑trial consistency.
- Contribute to regulatory submission strategy, ensuring external data and associated processes meet inspection and documentation requirements.
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
- Experience in oncology preferred.
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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