Specialist, EDC User Acceptance Testing, Quality Control & Development

Randstad; Hyderabad; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Randstad in Hyderabad seeks an EDC developer to build and validate Medidata Rave studies, including edit checks, dynamics, derivations, and custom functions.

You will configure study setup, manage UAT from plan to go-live, and conduct QC across internal and CRO builds, ensuring regulatory alignment and data integrity.

Required: 2+ years in EDC development, Medidata Rave experience, and strong collaboration in a matrix environment; additional certifications like Builder/TrialGrid are a plus.

Qualifications

• Bachelor's degree in mathematics, science, or a related field.
• 2+ years of EDC development experience in biotech, pharmaceutical, or healthcare.
• Medidata Rave experience required.
• Strong understanding of UAT methodologies, test script development, and defect management.
• Knowledge of 21 CFR Part 11, ICH-GCP, and CDISC standards.
• Robust knowledge of Data Management and Database Development processes.
• Strong cross-functional collaboration and time management in a matrix environment.
• UAT coordination or execution and QC of EDC systems strongly preferred.
• Medidata Builder Certification, C# programming, or TrialGrid knowledge a plus.

Responsibilities

• Build early to late phase studies in Medidata Rave, then program edit checks, dynamics, derivations, and custom functions in Rave Architect.
• Configure study setup, including user administration, AE/SAE alerts, IRT accounts, and Coder registration.
• Run UAT end-to-end from UAT Plan and site setup through test scripts, execution, and sign-off.
• Track, triage, and resolve UAT issues through to go-live.
• Conduct Quality Control on internal and CRO builds, covering eCRF design, edit checks, derivations, custom functions, and integrations.
• Document QC findings, verify corrections, and improve QC checklists, procedures, and UAT templates.
• Manage post-production changes through Rave Amendment Manager and support third-party integrations such as IxRS and labs.
• You bring a quality-focused mindset and strong attention to detail in resolving system defects.

Skills

Quality mindset

Attention to detail

Time management

Cross-functional collaboration

Education

Bachelor's degree in science/related field

Tools

Medidata Rave

C# programming

TrialGrid

Job description

Roles & Responsibilities:

• Build early to late phase studies in Medidata Rave, then program edit checks, dynamics, derivations, and custom functions in Rave Architect
• Configure study setup, including user administration, AE/SAE alerts, IRT accounts, and Coder registration
• Run UAT end-to-end from UAT Plan and site setup through test scripts, execution, and sign-off
• Track, triage, and resolve UAT issues through to go-live
• Conduct Quality Control on internal and CRO builds, covering eCRF design, edit checks, derivations, custom functions, and integrations
• Document QC findings, verify corrections, and improve QC checklists, procedures, and UAT templates
• Manage post-production changes through Rave Amendment Manager and support third-party integrations such as IxRS and labs
• You bring a quality-focused mindset and strong attention to detail in resolving system defects

This role requires:

• Bachelor's degree in mathematics, science, or a related field
• 2+ years of EDC development experience in biotech, pharmaceutical, or healthcare
• Medidata Rave experience required
• Strong understanding of UAT methodologies, test script development, and defect management
• Knowledge of 21 CFR Part 11, ICH-GCP, and CDISC standards
• Robust knowledge of Data Management and Database Development processes
• Strong cross-functional collaboration and time management in a matrix environment
• UAT coordination or execution and QC of EDC systems strongly preferred
• Medidata Builder Certification, C# programming, or TrialGrid knowledge a plus