Clinical Database Programmer (EDC)

Sigma-Chiconsulting; Hyderabad, Visakhapatnam; On-site; INR 800,000 - 1,600,000; Full time

Job summary

Sigma-Chi Consulting in Hyderabad, India is seeking a Clinical Database Programmer to build and maintain EDC study databases and edit checks, ensuring clean data from first patient in to database lock.

You design eCRFs, implement edit checks, manage changes, and support data transfers across global studies, with mentoring from senior programmers and exposure to AI-driven quality controls.

Qualifications

• Minimum 3–6 years of clinical database programming experience.
• Degree in Computer Science, Life Sciences, Pharmacy or a related field.
• Hands-on experience with at least one EDC system (e.g., Medidata Rave, Oracle InForm, Veeva Vault CDMS).
• Understanding of CDASH and SDTM.
• Good knowledge of GCP and 21 CFR Part 11.

Responsibilities

• Design and build eCRFs and study databases from the protocol and CRF specifications.
• Program and test edit checks, derivations and dynamic forms.
• Create and maintain data validation specifications.
• Manage database changes and mid-study updates.
• Support data transfers, external data integration and database lock activities.

Skills

CDASH

SDTM

GCP knowledge

21 CFR Part 11

Education

Degree in Computer Science, Life Sciences, Pharmacy or a related field

Tools

Medidata Rave

Oracle InForm

Veeva Vault CDMS

Job description

With more than a decade of experience, Sigma-Chi Consulting is a trusted biometrics partner to pharmaceutical and biotech sponsors, with teams in Hyderabad and Visakhapatnam supporting clients in the USA and Europe. We deliver biostatistics, statistical programming, clinical data management and AI-driven TLF quality control, with a strong focus on quality and on-time delivery.

Job Overview

As a Clinical Database Programmer you will build and maintain EDC study databases and edit checks that keep clinical data clean from first patient in to database lock.

Key Responsibilities

• Design and build eCRFs and study databases from the protocol and CRF specifications
• Program and test edit checks, derivations and dynamic forms
• Create and maintain data validation specifications
• Manage database changes and mid-study updates
• Support data transfers, external data integration and database lock activities

Requirements

• Degree in Computer Science, Life Sciences, Pharmacy or a related field
• 3-6 years of experience in clinical database programming
• Hands-on experience with at least one EDC system (for example Medidata Rave, Oracle InForm, Veeva Vault CDMS or similar)
• Understanding of CDASH and SDTM
• Good knowledge of GCP and 21 CFR Part 11

Good to have

• Custom function programming (for example C# in Rave)

What we offer

• Work on global pharma and biotech studies across therapeutic areas
• Mentoring from senior programmers and statisticians
• Exposure to our in-house AI tools for clinical reporting
• A collaborative team with clear career growth paths