Associate Director - External Data Acquisition Lead (EDAL)

Over de vacature

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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