Director, External Data Quality & Process

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

Benefits offered by this job

401(k) Plan: 100% match on the first 6

Health Benefits: Medical (HDHP with HS

Paid parental leave

Tuition reimbursement

Commuter benefits

Job summary

Genmab, a leading biotechnology company, is seeking a Director, Data Quality and Process, External Data Clinical Data Management. This role defines vision for external data quality, governance, and vendor oversight across Genmab's global portfolio.

You will collaborate with CDM, Clinical Operations, Biomarker Operations, Medical, Biostatistics, Regulatory, and external partners to ensure data quality, standardization, and inspection readiness throughout study lifecycles.

Qualifications

• Bachelor’s degree in a scientific, technical, or health-related field; advanced degree 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.
• Extensive experience managing external clinical data including laboratories, imaging, eCOA, IRT, biomarkers, wearables, and other third‑party data sources.
• Experience leading global CRO and vendor oversight.
• Experience developing clinical data management standards, processes, and governance.
• Experience supporting regulatory inspections and submission readiness. Strong understanding of end‑to‑end trial conduct.

Responsibilities

• Lead external data strategy, governance, and quality across the global clinical development portfolio.
• Oversee vendor relationships, CRO oversight, and performance metrics.
• Drive standardization, inspection readiness, and continuous process improvement across data management.
• Champion cross‑functional collaboration and governance meetings.
• Evaluate emerging technologies to improve data quality and operational efficiency.
• Represent Clinical Data Management in governance committees and industry initiatives.

Skills

Strategic leadership

Vendor oversight

External data management

Cross-functional leadership

ICH-GCP knowledge

Regulatory inspections

Education

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

MS or PhD preferred

Tools

EDC systems

Regulatory software

GDMP

Job description

Genmab, a leading biotechnology company, is seeking a Director, Data Quality and Process, External Data Clinical Data Management. This role defines vision for external data quality, governance, and vendor oversight across Genmab's global portfolio.

You will collaborate with CDM, Clinical Operations, Biomarker Operations, Medical, Biostatistics, Regulatory, and external partners to ensure data quality, standardization, and inspection readiness throughout study lifecycles.