Data Acquisition External (Remote)

About the Company

Genmab is an international biotechnology company focused on developing innovative antibody therapeutics for cancer and other serious diseases. Our teams combine scientific expertise, technology, and collaboration to advance clinical development and improve patient outcomes.

About the Role

We are seeking an Associate Director, External Data Acquisition Lead (EDAL) to provide strategic and operational leadership for the acquisition, integration, and quality oversight of third-party clinical data. This role serves as a subject matter expert for External Data Management, partnering with Clinical Data Management, Clinical Operations, vendors, and cross-functional teams to ensure external data is collected, transferred, integrated, and delivered in a timely, compliant, and analysis-ready manner. The ideal candidate brings extensive experience in clinical data management, external data acquisition, vendor oversight, data transfer specifications, CDISC standards, and global clinical trials, preferably within oncology.

Responsibilities

• External Data Acquisition & Integration
• Lead external data acquisition across clinical studies and programs
• Develop strategies to ensure high-quality, timely, and analysis-ready external data
• Advise study teams on external data collection requirements and integration feasibility
• Lead external data flow strategies across biomarker, central laboratory, imaging, PK/ADA, eCOA/ePRO, IRT, genomic, and other third-party data sources
• Ensure external data requirements align with clinical databases and study objectives
• Data Standards & Specifications
• Develop and maintain Data Transfer Specifications (DTS)
• Ensure vendor data is compatible with EDC and downstream clinical systems
• Align external data processes with CDASH, SDTM, and applicable CDISC standards
• Develop and maintain Trial Data Integrity Plans (TDIP) and data-flow documentation
• Ensure data is delivered in appropriate standardized formats for integration, analysis, and reporting
• Vendor Management
• Provide strategic oversight of external data vendors and service providers
• Review vendor budgets, change orders, technical requirements, and deliverables
• Partner with procurement, legal, and vendor management teams on technical contract language
• Act as an escalation point for complex vendor issues, including timeline delays and integration challenges
• Ensure vendor deliverables comply with protocol, ICH-GCP, SOPs, and applicable requirements
• Cross-Functional Leadership
• Partner with Clinical Data Management, Clinical Operations, Biometrics, vendors, and other stakeholders
• Represent Data Management in operational committees and governance forums
• Provide strategic guidance on external data acquisition and integration
• Lead process improvement, SOP development, standards governance, and technology optimization initiatives
• Promote consistency and scalability across clinical programs
• Leadership & Development
• Mentor and guide junior External Data Acquisition Leads
• Provide training on external data management processes and best practices
• Support knowledge-sharing initiatives across the organization
• Contribute to cross-functional task forces and strategic Data Management initiatives
• Help develop scalable processes and tools for Clinical Operations

Qualifications

• Bachelor's or Master's degree in a relevant technical or scientific discipline
• 10+ years of experience in clinical or external data management
• Strong experience with third-party clinical data acquisition and vendor oversight
• Experience supporting oncology clinical trials
• Strong knowledge of Data Transfer Specifications (DTS) and complex clinical data flows
• Experience integrating external data with EDC environments
• Knowledge of CDASH and SDTM
• Experience with diverse external data sources, including:
• Biomarkers
• Central laboratory data
• Imaging
• eCOA/ePRO
• Genomic data
• PK/ADA
• IRT
• Experience managing global projects, vendors, and process improvement initiatives
• Strong communication, analytical, organizational, and stakeholder-management skills

Preferred Skills

• Strong strategic thinking and clinical data management expertise
• Experience managing complex external data ecosystems
• Ability to translate technical requirements into practical operational solutions
• Strong vendor negotiation and issue-resolution capabilities
• Experience establishing standardized data management processes
• Ability to work effectively across global, cross-functional teams
• Strong mentoring and leadership capabilities
• Comfort working in a fast-paced, innovative biotechnology environment

Pay range and compensation package

Salary Range: $157,360 – $236,040

Eligible U.S. employees may receive:

• 401(k) with 100% match on the first 6% of contributions
• Medical, dental, and vision coverage
• Paid vacation, sick leave, and holidays
• 12 weeks of discretionary paid parental leave
• Commuter benefits
• Tuition reimbursement
• Lifestyle Spending Account
• Additional wellness and financial support programs

Equal Opportunity Statement

Genmab supports an agile working environment designed to encourage collaboration, innovation, and flexibility.