Clinical Database Designer (EDC / eCRF Specialist)
Location: Bengaluru, India
Job Type: Full-Time | Hybrid
Reference ID: R1528216
Company: IQVIA
About IQVIA
IQVIA is a global leader in clinical research services, healthcare intelligence, and commercial insights for the life sciences industry. The organization partners with pharmaceutical, biotechnology, and medical device companies to accelerate clinical development and commercialization of innovative therapies that improve patient outcomes worldwide.
This opportunity is ideal for professionals seeking to build or advance their career in clinical data management, electronic data capture (EDC), and clinical database design within a global CRO environment.
Role Overview
The Clinical Database Designer is responsible for study database design, edit check specifications, and system configuration within EDC platforms. This role ensures high-quality, compliant, and timely delivery of database components aligned with study protocols and regulatory standards.
The position requires close collaboration with data management teams, clinical operations, and project stakeholders to support accurate data capture and integrity across clinical trials.
Key Responsibilities
Clinical Study Database Design
Interpret clinical study protocols to design robust and compliant database structures.
Design and update electronic Case Report Forms (eCRFs).
Configure system settings, user rights and roles, and study-specific homepage components within EDC systems.
Complete Study Authorization Forms and Trial Capacity Request Forms (InForm).
Edit Check & Specification Development
Create and maintain Edit Specification Documents.
Generate specifications for EDC build components, including system validations and access controls.
Facilitate internal Edit Specification Review Meetings and lead technical discussions.
Stakeholder Collaboration & Meetings
Attend and contribute to Pre-Design Meetings, Online Screen Review Meetings, Internal Design Review Meetings, and Unblinded Data Review Meetings.
Present design feedback and ensure alignment with project objectives.
Communicate project risks to the Data Team Lead, including potential timeline deviations.
Escalate quality issues in a timely and structured manner.
Data Integrity & Compliance
Design databases to capture LLRR data accurately within the InForm platform.
Ensure appropriate user access levels are configured in the Rights and Roles documentation.
Ensure compliance with Standard Operating Procedures (SOPs) and complete all required project-specific training.
Review and provide input on database build timelines to ensure milestone adherence.
Required Experience
Total professional experience: 5+ years.
0–2 years of core experience in Clinical Database Design or Technical Design within a clinical data management environment.
Experience working with Electronic Data Capture (EDC) systems such as InForm or similar platforms preferred.
Exposure to eCRF design, edit checks, and clinical database configuration.
Understanding of clinical trial processes, GCP guidelines, and regulatory requirements.
Educational Qualifications
Bachelor’s degree in Science, Computer Science, Information Technology, or Bachelor of Technology (B.Tech) required.
Core Competencies
Clinical data management and database lifecycle knowledge
eCRF design and edit check development
EDC system configuration and user access management
Risk identification and quality issue escalation
Attention to detail and regulatory compliance focus
Strong communication and cross-functional collaboration skills
Why Join IQVIA
Work with one of the world’s leading clinical research organizations.
Gain exposure to global clinical trials and regulatory environments.
Build expertise in EDC systems, database design, and clinical data integrity.
Access structured learning and professional growth opportunities.
IQVIA maintains strict integrity standards in its recruitment process and enforces a zero-tolerance policy for candidate fraud or misrepresentation. All submitted credentials must be accurate and complete.
Advance your career in Clinical Data Management and EDC Database Design with IQVIA.
Explore more global clinical research and pharmaceutical opportunities at The Pharma Daily.
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