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
Solliciteren