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Associate Director - External Data Acquisition Lead (EDAL)


Overview

In this role you drive the end-to-end external data management for clinical trials, leading data acquisition from external providers and ensuring data quality and integration. You will partner with cross-functional teams to align data collection with trial objectives and regulatory standards. You shape external data strategies, governance, and vendor oversight to enable timely, analysis-ready data. This role offers the chance to impact oncology trials within a science-driven, collaborative culture and to mentor other data professionals.

Arbeidsvoorwaarden / Benefits
  • 401(k) plan with match
  • health, dental, and vision insurance
  • paid vacation, sick leave, holidays, parental leave
  • backup care and family support programs
  • tuition reimbursement
  • Lifestyle Spending Account
Verantwoordelijkheden
  • Lead external data acquisition across studies/programs with high-quality, timely data aligned to trial objectives
  • Advise on external data collection design and integration feasibility with CDASH/SDTM and EDC requirements
  • Plan and oversee external data flow strategies and data transfer systems across diverse data types
  • Collaborate with cross-functional stakeholders to ensure data acquisition supports operational and scientific goals
  • Develop and manage Trial Data Integrity Plans (TDIP) and data flow documentation
  • Create and maintain DTS requirements; ensure vendor data aligns with SDTM and clinical database needs
  • Review external vendor budgets and change orders; act as escalation point for complex vendor issues
  • Mentor junior External Data Acquisition Leads and lead cross-functional initiatives
  • Partner with procurement/legal to review contracts and ensure alignment with Genmab standards
  • Promote consistency and scalability through training, knowledge sharing, and strategic planning
Belangrijkste vereisten
  • 10+ years in external or clinical data management with strong third-party vendor oversight
  • Experience on Oncology trials/data and governance of DTS and complex data flows for EDC integration
  • Knowledge of diverse external data types (biomarker, central lab, imaging, eCOA/ePRO, genomic) and alignment with objectives
  • Experience managing projects, vendors, and process improvements in global environments
  • Proven performance in a prior role
  • collaboration
  • leadership
  • mentoring
  • CDISC standards (CDASH, SDTM)
  • EDC (electronic data capture) systems
  • TDIP and data flow management

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