Design, develop, validate, and maintain clinical study databases within EDC systems, ensuring data quality, protocol compliance, and timely study deliverables
Job Summary
Design, develop, validate, and maintain clinical study databases within EDC systems, ensuring data quality, protocol compliance, and timely study deliverables.
Ensure compliance with GCP, CDISC standards, and 21 CFR Part 11 requirements, while maintaining study documentation and collaborating with cross-functional teams.
Syngene is an innovation-led contract research, development and manufacturing organization committed to safety and quality standards in all operations.
Matching Summary
Design, develop, validate, and maintain clinical study databases within EDC systems, ensuring data quality, protocol compliance, and timely study deliverables.
Skills & Requirements
Must-have
EDC database programming
clinical trials
database build, testing, maintenance
edit checks and validation rules
GCP, CDISC, 21 CFR Part 11
Nice-to-have
accountability and ownership
proactive communication
collaborative team player
willingness to learn
positive team contribution
Key Requirements
Hands-on experience in EDC database programming
Experience working on Phase I–IV studies
Bachelor’s/master’s degree in Computer Science/IT
Training in GCP, CDISC, or clinical data management