Description
We are seeking a Study Designer to join our team. As a Study Designer, you will be responsible for study build and design, editing specifications, system configurations, and associated study design components. You will collaborate with various stakeholders, including DTL, Programmer, Validation Team, vendors, statisticians, and client representatives. In addition to project deliveries, you will also be responsible for project financials from a programming shared services perspective.
Essential Functions:
- Interpret the study protocol
- Design and update the eCRF within Medidata RAVE and other platforms as required
- Create and update Edit Specification Document
- Generate specifications for EDC build components (e.g., Rights and Roles, System Settings and Home Page)
- Attend meetings, including Pre-Design Meeting, Online Screen Review Meeting, Unblinded Data review meeting, and Internal Design Review Meeting
- Facilitate internal Edit Specification Review Meeting and lead discussions regarding the Edit Specification Document
- Communicate project risks to the Data Team Lead
- Escalate potential quality issues
- Ensure completion and documentation of all project-specific training
- Review build timelines and provide input as applicable
- Review budgets for own projects and identify out-of-scope activities
- Identify areas for process improvements and contribute to process improvement initiatives
Qualifications:
- Bachelor's Degree in Science/Computer Science/Information Technology or Bachelor in Technology
- 2-4 years of relevant RAVE designer experience and total experience being 7+ years