About this role
Role Overview
- Responsible for study build & design, edit specifications, system configurations.
- Collaborate with various stakeholders
- DTL, Programmer, Validation Team, vendors, statisticians, and client representatives.
- Handle project financials from programming shared services perspective.
- Interprets the study protocol.
- Design and update the eCRF using CDMS tools in alignment with industry standards.
- Create and update Edit Specification Document.
- Generate specifications for EDC build components.
- Complete the Study Authorization Form and Trial Capacity Request Form.
- Attend and present comments at various meetings.
- Facilitate the internal Edit Specification Review Meeting.
- Design the database to collect data within the InForm database.
- Communicate any project risks.
- Ensure the completion and documentation of all project-specific training.
- Reviews build timelines and provides input as applicable.
- Responsible for multiple study design projects at the same time.
Requirements
- Bachelor's Degree in Science/Computer science/Information or Technology is mandatory.
- 4 to 6 years of relevant core technical designer experience.
- 9 years of overall experience in clinical research data management.
- Hands-on experience designing in Medidata RAVE.
- Based in Latinamerica, home base role.
Benefits
- Professional development opportunities