Associate Director - External Data Acquisition Lead; EDAL

At Genmab, we are dedicated to building extra not ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

The Role:

The Associate Director, External Data Acquisition Lead (EDAL) role is a clinical data manager with expertise in the data collection of 3rd party data from various external providers (e.g. laboratories, eCOA providers, technology providers, etc.). The EDAL provides a leadership role in the oversight of the external clinical data integration processes as well as oversight of data quality from various external providers performing testing or data collection services on behalf of Genmab.

The EDAL serves as the subject matter expert for all external data management activities performed for clinical trial teams. This role provides strategic data management expertise and is accountable for all end-to-end Data Management activities and deliverables pertaining to external data. The employee will provide oversight of external vendors and the data and/or data services they provide to Genmab. The External Data Lead will support the development and optimization of processes and tools to enable success of the Clinical Operations department.

The employee will represent Data Management in Operational Committee's/fora with the partners and/or DM/stat vendors. The employee will support /train colleagues in and advise on handling of external data management related processes/issues and may act as a mentor. Moreover, the employee shall support the overall strategy and development of Data Management by attending/leading task force initiatives within the department and/or as part of cross-departmental teams.

Responibilites
:

• Lead external data acquisition across one or more studies/programs, ensuring high-quality, timely, analysis-ready data aligned with trial objectives.
• Influence protocol and amendment development by advising on external data collection design, integration feasibility, and alignment with CDASH/SDTM and EDC requirements.
• Lead planning and oversight of external data flow strategies and DTS across diverse data types (PK/ADA, biomarker, imaging, central lab, eCOA/ePRO, PD, IRT, etc.) to ensure compliant integration.
• Partner with cross-functional stakeholders to ensure external data acquisition supports operational and scientific goals.
• Develop and manage Trial Data Integrity Plans (TDIP) and Data Flow
• Create and maintain data transfer specifications (DTS) requirements. Ensure data collection requirements are aligned with external vendor capabilities and vendor data are compatible with the clinical database and SDTM requirements to support data integration, analysis and reporting. Ensure vendor data is transferred in standard data formats.
• Provide thorough review of external vendors budget and change order
• Act as escalation point for complex vendor issues (timeline deviations, integration challenges, misalignment to trial needs).
• Mentor and guide junior External Data Acquisition Leads, providing direction on best practices, issue resolution, and development.
• Lead cross-functional initiatives including SOP development, process improvement, tools optimization, and external data standards governance.
• Partner with procurement/legal/vendor managers to review technical language in contracts and work orders, ensuring alignment with Genmab standards and systems.
• Promote portfolio-level consistency and scalability through training, knowledge sharing, and strategic planning support.
• Mentor and develop team members to ensure consistency of External Data Management practices.
• Ensure External Vendor deliverables are performed in compliance with protocol, ICH, GCP and SOPs

Requirements:

• Bachelor's or Master's degree in a relevant technical area;
  Master's degree preferred.
• 10+ years of experience in external or clinical data management, with strong third-party vendor oversight and data acquisition experience.
• Experience designing and governing DTS and complex data flows supporting EDC integration and CDISC standards (CDASH, SDTM).
• Strong knowledge of diverse external data types (e.g., biomarker, central lab, imaging, eCOA/ePRO, genomic) and ability to align acquisition strategies to clinical and analytical objectives.
• Experience managing…