Genmab · 2 weeks ago
Associate Director, External Data Quality Manager
Plainsboro, NJ
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$147K/yr - $220K/yr
10+ years expGenmab is an international biotechnology company dedicated to improving the lives of patients through innovative antibody therapeutics. The Associate Director, External Data Quality Management, will lead strategic initiatives to ensure high-quality execution of clinical trial data, overseeing external data quality and vendor performance while collaborating with cross-functional teams.
BiotechnologyHealth CareManufacturingMedical
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
Contribute to asset‑level planning, governance forums, and clinical development strategy discussions
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
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
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
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
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
Qualification
Required
Bachelor's degree in a scientific, technical, or health-related field
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
Preferred
Advanced degree (MS, PhD)
Experience in oncology
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
Company
Genmab
Genmab is a biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer.
1001-5000 employees
H1B Sponsorship
Genmab has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (10)
2023 (6)
2022 (3)
2021 (3)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$11.7BKey Investors
Morgan Stanley Senior FundingGlaxoSmithKlineIndex Ventures
2025-11-18Post Ipo Debt· $6B
2025-09-29Post Ipo Debt· $5.5B
2010-07-01Post Ipo Equity· $134M
Leadership Team
Anthony Pagano
Chief Financial Officer
Anthony Mancini
EVP & Chief Operating Officer
Recent News
2026-01-08
Company data provided by crunchbase