Clinical Study Builder – EDC / Data Management
Location: India (Remote / Home-Based)
Employment Type: Permanent, Full-Time
Industry: Clinical Research / CRO / Life Sciences
Experience Required: 2–4 Years
Company: Indero
Role Overview
Indero is seeking an experienced Clinical Study Builder to support global clinical research programs by designing, building, and maintaining high-quality electronic data capture (EDC) solutions. This role collaborates closely with Data Management and Biostatistics teams to develop electronic case report forms (eCRFs), visit schedules, and data validation checks in compliance with regulatory standards and sponsor requirements.
The position primarily focuses on Medidata Rave CDMS, with additional exposure to Veeva EDC and Medrio, making it an excellent opportunity for professionals specializing in EDC study build and clinical data systems.
Key Responsibilities
EDC Study Build and Configuration
Design, program, and configure eCRFs, folders, visit schedules, edit checks, derivations, reports, integrations, and migrations using Medidata Rave CDMS
Support study build activities in additional EDC platforms such as Veeva EDC and Medrio, as required
Configure Coder, Local Lab, and Targeted SDV modules
Study Design and Stakeholder Collaboration
Lead eCRF design and review meetings with internal teams and sponsors
Collaborate closely with Lead Data Managers to align study builds with protocol requirements
Work with external vendors and partners during testing, UAT, and deployment phases
Testing, Support, and Training
Perform comprehensive testing of study builds and integrations to ensure data quality and system reliability
Provide technical and user support throughout the study lifecycle
Conduct end-user training for study teams and stakeholders
Quality, Compliance, and Documentation
Ensure all study build activities comply with ICH-GCP guidelines, regulatory requirements, and Indero SOPs
Participate in the development, review, and maintenance of Rave CDMS SOPs
Troubleshoot and resolve technical issues efficiently while maintaining study timelines
Required Qualifications and Experience
Education
Bachelor’s or Master’s degree (B.Sc. or M.Sc.) in life sciences, computer science, biotechnology, pharmacy, or a related field
Experience
Minimum 2–4 years of hands-on study build experience using Medidata Rave CDMS
Experience managing multiple concurrent study builds or post-production changes
Technical Skills and Knowledge
Strong expertise in eCRF design, database programming, and clinical data systems
Working knowledge of the drug development lifecycle and clinical trial regulations
In-depth understanding of ICH Guidelines, Good Clinical Practice (GCP), and regulatory compliance
Certified Rave Study Builder is preferred
Experience with Veeva EDC and Medrio is an advantage
Professional Skills
Highly organized with strong project planning and time management capabilities
Excellent written and verbal communication skills in English
Ability to work in a fast-paced, global environment with multiple competing priorities
Strong problem-solving skills and attention to detail
Work Environment and Benefits
At Indero, you will be part of a collaborative and innovation-driven work culture. The organization values reliability, responsiveness, and teamwork, offering professionals a stimulating environment with long-term career growth opportunities.
Position Highlights:
Permanent, full-time employment
Flexible work schedule
Ongoing learning and professional development
Remote, home-based role in India
Please note that occasional attendance at meetings outside regular business hours (primarily evenings) may be required to support global stakeholders.
About Indero
Indero, formerly known as Innovaderm, is a globally recognized Contract Research Organization specializing in dermatology and rheumatology clinical research. With more than 25 years of experience, Indero delivers end-to-end clinical trial solutions, including protocol design, patient recruitment, monitoring, data management, and biometrics.
With operations across North America, Europe, Asia Pacific, and Latin America, Indero partners with biotechnology and pharmaceutical companies to deliver high-quality, scientifically rigorous clinical trials at a global scale.
Equal Opportunity Statement
Indero is committed to providing equal employment opportunities and equitable treatment for all applicants. Reasonable accommodations are available throughout the recruitment process for individuals with disabilities, upon request.
Eligibility: Applicants must be legally authorized to work in India.
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