Director, External Data Quality & Process Excellence

Genmab A/S; Princeton (NJ); On-site; USD 189,200 - 283,800; Full time

Benefits offered by this job

401(k) match

Health benefits (medical, dental, and视

Paid time off

Job summary

Genmab A/S in Princeton, NJ is seeking a Director, Data Quality and Process, External Data Clinical Data Management.

This strategic role defines the vision for external data quality, oversees vendor data sources, and drives governance across Genmab’s global clinical development portfolio, partnering with CDM, Clinical Operations, Medical, Biostatistics and Regulatory to ensure high-quality data throughout studies.

Qualifications

• Bachelor’s degree in a scientific/technical/health field; MS/PhD preferred.
• Minimum 15+ years of clinical research or clinical data management experience.
• Minimum 5 years in strategic leadership within Clinical Data Management or External Data Management.
• Experience managing external data sources (labs, imaging, eCOA, biomarkers) and global CROs.

Responsibilities

• Define and lead external data quality and process governance.
• Develop and execute strategic roadmap for data quality, operations and governance.
• Standardize processes across studies and vendors; drive governance models and metrics.
• Lead vendor qualification, RFPs, bid defenses, and SOW reviews; partner to improve quality.
• Ensure inspection readiness and regulatory compliance; support audits and CAPAs.
• Drive cross-functional governance and collaboration across teams.

Skills

Project Management

Strategic Planning

Cross-functional Leadership

Analytical Thinking

Regulatory Knowledge

Education

Bachelor's degree in a scientific/technical/health-related field

MS/PhD preferred

Tools

EDC systems

Regulatory guidance portals

Job description

Genmab A/S in Princeton, NJ is seeking a Director, Data Quality and Process, External Data Clinical Data Management.

This strategic role defines the vision for external data quality, oversees vendor data sources, and drives governance across Genmab’s global clinical development portfolio, partnering with CDM, Clinical Operations, Medical, Biostatistics and Regulatory to ensure high-quality data throughout studies.