Job Description
Hiring: Technical Lead Clinical Database & Applications (4+ Yrs)
We are hiring a Technical Lead to drive database development and validation for clinical trial applications (EDC, CTMS, eTMF). This is a purely technical database role, not a clinical operations position.
Key Responsibilities
Required Skills
Compliance: Strong GxP, CSV documentation, and audit-readiness practices.
Systems: Hands-on setup/implementation of EDC, CTMS, or eTMF software.
Technical: Advanced SQL & PL/SQL, database schema design, and backend edit check scripting.
Experience: 4+ years in database engineering within Life Sciences/Clinical Tech.
System Validation (CSV): Act as CSV Lead; manage UAT, design Test Plans/Cases, maintain RTMs, and ensure 100% compliance with FDA 21 CFR Part 11 and ICH-GCP.
Data & Troubleshooting: Perform data extraction, script-based reconciliation, data correction, and technical troubleshooting.
Team Leadership: Lead a technical team of 6 developers and testers to implement client and internal software systems.
Database Engineering: Design database structures for EDC systems; write advanced SQL/PL-SQL procedures, views, and anonymous blocks for complex edit checks.
Technical: Advanced SQL & PL/SQL, database schema design, and backend edit check scripting.
No Referrers Available
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