Clinical Database Designer
Location: Kochi, India
Job Type: Full-Time
Application Deadline: June 30, 2026
Job Requisition ID: R1536965
About the Role
We are seeking a detail-oriented Clinical Database Designer to support the design, configuration, and maintenance of clinical study databases. In this role, you will be responsible for translating study protocols into electronic data capture (EDC) solutions, developing electronic Case Report Forms (eCRFs), and creating edit specifications that ensure accurate and compliant clinical data collection.
You will collaborate closely with Data Management teams, project stakeholders, and study teams to ensure high-quality database design, timely project delivery, and adherence to regulatory and organizational standards.
Key Responsibilities
Clinical Study Design & Database Development
Interpret clinical study protocols and translate requirements into database design specifications.
Design, configure, and maintain clinical databases within Electronic Data Capture (EDC) systems.
Develop and update Electronic Case Report Forms (eCRFs).
Ensure database structures accurately support study objectives and data collection requirements.
Edit Checks & Specifications
Create, review, and maintain Edit Specification Documents.
Define and document data validation rules and edit checks.
Facilitate internal review meetings for edit specifications and lead discussions with project stakeholders.
Ensure consistency and quality of edit check implementation across studies.
System Configuration
Generate specifications for EDC build components, including:
Rights & Roles Configuration
System Settings
Study Home Pages
User Access Controls
Complete required study setup documentation and authorization forms.
Configure database settings according to study requirements and compliance standards.
Meeting Participation & Stakeholder Collaboration
Participate in key study meetings, including:
Pre-Design Meetings
Online Screen Review Meetings
Unblinded Data Review Meetings
Internal Design Review Meetings
Present design feedback and recommendations.
Collaborate with Data Managers, Clinical Teams, and Project Stakeholders throughout study setup and execution.
Data Integrity & Compliance
Design databases to support collection of protocol-specific data requirements.
Ensure appropriate user access and security permissions are implemented.
Maintain compliance with Standard Operating Procedures (SOPs), regulatory guidelines, and company quality standards.
Identify and escalate potential quality issues and project risks.
Project Delivery & Risk Management
Monitor study build timelines and provide input on project planning.
Communicate risks that may impact project milestones or delivery schedules.
Support timely completion of assigned study design deliverables.
Ensure all project-specific training requirements are completed and documented.
Required Qualifications
Education
Bachelor’s Degree in one of the following:
Computer Science
Information Technology
Life Sciences
Engineering (B.Tech)
Related Technical Discipline
Experience
0–2 years of direct Clinical Database Design or Technical Design experience.
Overall professional experience of 5+ years preferred.
Experience working with Clinical Data Management processes is advantageous.
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