Associate Director - External Data Acquisition Lead (EDAL)

The Role: The Associate Director, External Data Acquisition Lead (EDAL) is a clinical data manager with expertise in collecting third‑party data from external providers such as laboratories, eCOA providers, and technology vendors. The EDAL leads oversight of external clinical data integration processes and data quality assurance for services performed on behalf of Genmab. As the subject‑matter expert, the EDAL provides strategic data management expertise and is accountable for all end‑to‑end data management activities and deliverables pertaining to external data. The role includes oversight of external vendors and the data and services they provide, support for process and tool development, representation of Data Management in operational committees, training of colleagues, and leadership of cross‑departmental initiatives. Responsibilities 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, ensuring alignment with vendor capabilities and compatibility with the clinical database and SDTM requirements for analysis and reporting. Provide thorough review of external vendors’ budgets and change orders. Act as escalation point for complex vendor issues (timeline deviations, integration challenges, misalignment to trial needs). Mentor and guide junior External Data Acquisition Leads on best practices and issue resolution. 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. Ensure External Vendor deliverables comply with protocol, ICH, GCP, and SOPs. Requirements Bachelor’s or Master’s degree in a relevant technical area; Master’s 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 projects, vendors, and process improvements in global environments. Proven performance in earlier roles. Benefits For US based candidates, the proposed salary band for this position is as follows: $157,360.00 — $236,040.00 In addition to salary, regular full‑time U.S. employees are eligible for: 401(k) Plan: 100% match on the first 6% of contributions Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary Plans: Critical illness, accident, and hospital indemnity insurance Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well‑being support Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses About You You are genuinely passionate about our purpose. You bring precision and excellence to all that you do. You believe in our rooted‑in‑science approach to problem‑solving. You are a generous collaborator who can work in teams with a broad spectrum of backgrounds. You take pride in enabling the best work of others on the team. You can grapple with the unknown and be innovative. You have experience working in a fast‑growing, dynamic company (or a strong desire to). You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work‑life balance. Our offices are crafted as open, community‑based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you are in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. #J-18808-Ljbffr