Syngene International Ltd is hiring experienced professionals for the position of Analyst – Clinical Data Management / EDC Database Programmer in Bangalore, India. This opportunity is ideal for candidates with experience in clinical data management, EDC database programming, and clinical trial data systems.
The role focuses on designing, developing, validating, and maintaining clinical study databases in Electronic Data Capture (EDC) systems, ensuring compliance with GCP, CDISC standards, and regulatory requirements. Candidates with experience in Medidata Rave, Veeva, Inform, Clinion, or equivalent EDC platforms are strongly encouraged to apply.
Working at Syngene, a leading contract research, development, and manufacturing organization (CRDMO), provides exposure to global clinical trials across Phase I–IV studies, enabling professionals to build expertise in clinical trial data systems and regulatory-compliant data management processes.
Job Details
| Field | Details |
|---|---|
| Position | Analyst – Clinical Data Management (EDC Database Programmer) |
| Company | Syngene International Ltd |
| Location | Bangalore, India |
| Department | Clinical Data Management |
| Division | Discovery Services |
| Job Type | Full-time |
| Experience | Experienced candidates preferred |
| Industry | Clinical Research / CRO |
Key Responsibilities
The Clinical Data Management Analyst / EDC Database Programmer will support clinical trial database development and maintenance activities.
Database Development & Study Setup
- Design and develop clinical study databases within EDC systems according to protocol and CRF specifications.
- Configure electronic Case Report Forms (eCRFs), visit schedules, derivations, edit checks, and workflows.
- Translate clinical protocols into database design specifications.
Database Validation & Testing
- Perform database validation and User Acceptance Testing (UAT).
- Develop and maintain edit check specifications and test scripts.
- Ensure system compliance with 21 CFR Part 11 regulatory requirements.
Data Quality & Data Cleaning
- Support clinical data cleaning activities and resolve system-related data queries.
- Troubleshoot issues within EDC systems and collaborate with clinical teams.
Study Maintenance & Updates
- Implement mid-study updates and amendments following change control processes.
- Maintain audit trails, validation records, and build documentation.
Cross-Functional Collaboration
- Work with clinical operations, data management, biostatistics, and sponsors.
- Support database lock activities and integrations with systems such as ePRO, IWRS, and laboratory data systems.
Required Qualifications
Candidates applying for the Syngene Clinical Data Management Analyst role should meet the following qualifications.
Education
- Bachelor’s or Master’s degree in:
- Computer Science
- Information Technology
Additional training in GCP, CDISC, or Clinical Data Management is advantageous.
Experience
- Hands-on experience with EDC database programming in clinical trials.
- Exposure to Phase I–IV clinical studies is preferred.
- Experience in database build, validation, and maintenance activities.
Technical Skills
- Proficiency in EDC platforms such as:
- Medidata Rave
- Oracle Inform
- Veeva
- Clinion
- Understanding of CDISC standards and GCP guidelines.
- Strong analytical and troubleshooting skills.
Soft Skills
- Strong attention to detail and commitment to clinical data quality.
- Ability to work in deadline-driven clinical research environments.
- Effective communication and teamwork skills.
Why Join Syngene?
Syngene is one of India’s leading contract research organizations (CROs) providing integrated services from drug discovery to commercial manufacturing.
Career Benefits
- Work on global clinical trials and research programs
- Exposure to advanced EDC systems and clinical data platforms
- Opportunities for career growth in clinical data management and clinical research
- Collaborative environment with cross-functional research teams
How to Apply
