Overview
In this role you will design and configure study data collection and specifications to support clinical trials, collaborating with cross-functional teams to ensure compliant, timely delivery. You will translate study protocols into CDMS configurations, author/edit data specifications, and manage study-related documentation and risks. You’ll contribute to project finances within programming shared services and lead design review discussions to drive accurate, scalable study builds. This position offers the opportunity to influence data capture standards and support continuous process improvements in a regulated environment.
Responsibilities
- Interpret study protocol and translate into study design components
- Design and update eCRF using CDMS tools aligned with SDTM/CDASH
- Create and update Edit Specification Document
- Generate specifications for EDC build components (Rights and Roles, System Settings, Home Page)
- Lead/participate in design review meetings and edit spec discussions
- Design databases to capture LLRR data within InForm with proper access controls
- Communicate project risks and potential timeline impacts to Data Team Lead
- Escalate quality issues and ensure training and SOP adherence
- Review build timelines and project QIP, identify out-of-scope activities
- Manage multiple study design projects across platforms and drive process improvements
Key requirements
- Bachelor in Science/Computer science/Information Technology or Bachelor in Technology
- 2-4 years of relevant core technical designer experience
- Total experience 7+ years
- collaboration
- communication
- risk assessment
- eCRF design
- CDMS tools (third party or in-house)
- SDTM
Snr Clinical Database Designer in Reading employer: IQVIA
At IQVIA, we pride ourselves on being an exceptional employer, offering a dynamic work culture that prioritises innovation and employee well-being. Our South West England location provides flexible working arrangements, comprehensive well-being support, and robust career development opportunities through our AI-powered talent marketplace, ensuring that you can thrive both personally and professionally while contributing to meaningful advancements in healthcare.
