Data Acquisition - Remote

## About the Role

Genmab is seeking an **Associate Director, External Data Acquisition Lead (EDAL)** to provide strategic leadership and subject-matter expertise in external clinical data management. The role oversees the acquisition, integration, quality, and end-to-end management of third-party clinical data across global clinical trials, including oncology studies.

## Key Responsibilities

• * Lead external data acquisition across one or more studies or programs.
• * Ensure high-quality, timely, and analysis-ready external data aligned with trial objectives.
• * Advise on external data collection design, integration feasibility, and protocol amendments.
• * Lead external data flow strategies and **Data Transfer Specifications (DTS)** across diverse data types.
• * Oversee integration of PK/ADA, biomarker, imaging, central laboratory, eCOA/ePRO, PD, IRT, and other external data.
• * Develop and manage **Trial Data Integrity Plans (TDIP)** and data-flow requirements.
• * Ensure vendor data is compatible with clinical databases and **CDISC standards**, including CDASH and SDTM.
• * Review external vendor budgets and change orders.
• * Act as an escalation point for complex vendor, timeline, and integration issues.
• * Mentor and guide junior External Data Acquisition Leads and team members.
• * Lead SOP development, process improvement, tool optimization, and external data standards governance.
• * Partner with procurement, legal, and vendor management teams on contracts and work orders.
• * Promote portfolio-level consistency and scalability through training and knowledge sharing.
• * Ensure external vendor deliverables comply with protocol, **ICH, GCP, and SOPs**.
• * Represent Data Management in operational committees and cross-functional forums.

## Required Qualifications

• * Bachelor's or Master's degree in a relevant technical field; Master's preferred.
• * **10+ years of experience** in external or clinical data management.
• * Strong third-party vendor oversight and data acquisition experience.
• * Experience working on **oncology trials/data**.
• * Experience designing and governing DTS and complex data flows supporting EDC integration.
• * Strong knowledge of **CDISC, CDASH, and SDTM** standards.
• * Experience with diverse external clinical data types such as biomarkers, central lab, imaging, eCOA/ePRO, and genomic data.
• * Experience managing projects, vendors, and process improvements in global environments.
• * Proven performance in previous roles.

## Preferred Qualifications

• * Master's degree in a relevant technical discipline.
• * Broad experience across multiple external clinical data modalities.
• * Experience developing scalable external data management processes and standards.
• * Experience mentoring and developing clinical data management professionals.
• * Experience collaborating with procurement, legal, and vendor management teams.

## Skills & Competencies

• * External Clinical Data Management
• * External Data Acquisition
• * Clinical Data Integration
• * Data Transfer Specifications (DTS)
• * CDISC / CDASH / SDTM
• * EDC Integration
• * Trial Data Integrity Plans (TDIP)
• * Vendor Management
• * Data Quality Management
• * Oncology Cl