Clinical Database Designer (Mumbai)
Core
Design and maintain electronic Case Report Form (eCRF) specifications and edit check specifications for clinical trials, ensuring data quality and protocol compliance.
Role type
Clinical Database Designer
Builds
Study-specific eCRF libraries and edit check specifications for clinical data collection
Domain
Clinical Research / Biopharmaceuticals
Required skills
eCRF specification design, Edit Check Specification development, CDISC standards, EDC system configuration, UAT validation, Report design
Preferred skills
Protocol review, Stakeholder liaison, Technical design decision making
Technologies
Business Objects, JReview, EDC systems
Responsibilities
Maintain eCRF and Edit Check Specification standard templates according to CDISC standards; Develop and maintain eCRF specifications on a study-by-study basis; Perform validation of eCRF and edits; Liaise with Data Managers and Sponsors to ensure EDC database setup; Design customized project-level reports; Lead eCRF specification review meetings.
Seniority
Mid-level, hands-on IC