Associate Director, External Data Quality Manager
Company: Genmab
Job ID: R15039
Category: Development Operations
Location: United States (Remote / New Jersey)
Work Model: Remote / Hybrid
Career Level: Associate Director
Job Overview
Genmab is seeking an Associate Director, External Data Quality Management to lead strategic and operational oversight of external data quality across clinical trials. This pivotal role ensures the integrity, consistency, and high-quality execution of clinical trial data from third-party sources such as central/local labs, imaging, eCOA, and biomarkers.
The Associate Director will provide portfolio-level leadership, guide cross-functional teams, manage vendor performance, and drive harmonized operational approaches that support trial delivery, regulatory inspection readiness, and data-informed decision-making.
Key Responsibilities
Portfolio and Strategic Leadership
Lead portfolio-level external data quality and clinical data operational strategy.
Ensure process consistency, quality standards, and documentation across studies and vendors.
Provide strategic insights for risk, timelines, and data-dependent operational decisions.
Contribute to clinical development strategy, governance forums, and asset-level planning.
External Data Quality Oversight
Oversee quality assurance of third-party data acquisition, integration, and management.
Review protocols, vendor specifications, and operational data flows to ensure compliance.
Lead proactive surveillance of external data quality and manage escalations.
Cross-Functional Collaboration
Work closely with Trial Management, Clinical Programming, Biostatistics, Medical Writing, and Biomarker Operations to ensure aligned execution and issue resolution.
Facilitate operational readiness and understanding of external data processes across teams.
Participate in governance forums and portfolio-level data planning initiatives.
Process Excellence and Standardization
Drive continuous improvement initiatives to enhance efficiency, consistency, and inspection readiness.
Develop standardized processes, playbooks, RACI models, and best practices.
Identify operational bottlenecks and provide scalable, portfolio-level solutions.
Vendor and Partnership Oversight
Strategically manage external vendors handling clinical data, focusing on performance, compliance, and cross-trial consistency.
Represent External Data Quality Management in operational committees and vendor interactions.
Regulatory and Submission Support
Contribute to regulatory submission strategy and ensure external data meets inspection and documentation requirements.
Provide oversight of data-related deliverables for submissions.
Additional Responsibilities
Lead alignment meetings within the Data Management group for consistency across trials.
Mentor and develop team members and contribute to SOPs and best practices.
Serve as Portfolio Asset External Data Quality Management Lead as required.
Required Qualifications
Bachelor’s degree in scientific, technical, or health-related field; advanced degree (MS, PhD) preferred
Minimum 10 years clinical operations, clinical data management, or related experience, including 3–5 years in oversight or leadership roles
Strong knowledge of end-to-end clinical trial conduct and project management
Expertise in operational excellence, process improvement, and strategic planning
Cross-functional alignment, communication, and problem-solving skills
Experience in vendor oversight and partnership management
Familiarity with EDC systems, ICH-GCP, GDMP, and regulatory requirements
Oncology experience preferred
Compensation (US-Based Roles)
Salary Range: USD 146,640 – 219,960 annually
Actual salary will depend on candidate qualifications, experience, and location. Additional forms of compensation may include discretionary bonuses and long-term incentives.
Employee Benefits
401(k) plan with 100% match on first 6% contributions
Comprehensive medical, dental, and vision insurance options
Paid vacation, sick leave, holidays, and 12 weeks discretionary paid parental leave
Wellness, lifestyle, and tuition reimbursement programs
Family care, financial wellness, and emotional support programs
Commuter benefits and Lifestyle Spending Account for personal and wellness expenses
About You
Passionate about improving patient outcomes and advancing science
Precise, detail-oriented, and committed to excellence
Rooted-in-science approach to problem-solving
Collaborative, innovative, and able to thrive in fast-growing environments
Enjoy working hard while contributing positively to team culture
About Genmab
Genmab is a global biotechnology company committed to transforming the lives of patients through innovative antibody therapeutics. With 25 years of expertise in next-generation antibody platforms, translational science, and data-driven innovation, Genmab develops life-changing therapies in oncology and serious diseases. Headquartered in Copenhagen, Denmark, Genmab has a global presence across North America, Europe, and Asia-Pacific.
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