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
Associate Director - External Data Acquisition Lead (EDAL) in Utrecht werkgever: Jobrapido
StarPark is een uitstekende werkgever die je de kans biedt om te werken op diverse evenementen en festivals, waar je in een informele en prettige werksfeer kunt bijdragen aan de veiligheid van bezoekers. Met flexibele werkmogelijkheden en goede begeleiding vanuit het team, stimuleert StarPark persoonlijke groei en ontwikkeling, waardoor je niet alleen waardevolle ervaring opdoet, maar ook de mogelijkheid hebt om door te groeien binnen de organisatie. Wij verwelkomen iedereen, ongeacht achtergrond, en geloven dat jouw talent het belangrijkste is.
