PLSQL Developer

Clinevo Technologies; Electronic City; On-site; INR 3,000,000 - 5,000,000; Full time

Job summary

Clinevo Technologies is seeking a Technical Lead to drive database development and validation for clinical trial applications (EDC, CTMS, eTMF). This purely technical role focuses on database engineering, not clinical operations.

The ideal candidate has 4+ years of experience in Life Sciences/Clinical Tech, strong GxP and CSV practices, and proven leadership of a 6-person technical team to deliver compliant systems.

Qualifications

• Professional experience in Life Sciences/Clinical Tech.
• 4+ years in database engineering in Life Sciences/Clinical Tech.
• Hands-on setup/implementation of clinical trial software (EDC/CTMS/eTMF).
• Designing database structures and advanced SQL/PL-SQL procedures.
• Lead CSV activities ensuring 21 CFR Part 11 compliance.

Responsibilities

• Drive database development and validation for clinical trial applications.
• Lead a technical team of developers and testers.
• Ensure audit-readiness and CSV documentation.
• Manage UAT, Test Plans/Cases, RTMs and compliance with FDA 21 CFR Part 11 and ICH-GCP.
• Perform data extraction, data reconciliation, and troubleshooting.

Skills

GxP compliance

CSV documentation

EDC/CTMS/eTMF

SQL & PL/SQL

Database schema design

FDA 21 CFR Part 11

UAT & Test Plans

Team leadership

Data troubleshooting

Edit checks scripting

Tools

EDC

CTMS

eTMF

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.

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.