Clinical Study Builder – EDC Systems (India)
Location: India (Remote / Home-based)
Employment Type: Permanent, Full-time
Career Level: Professional
About the Company
Indero is a globally recognized Clinical Research Organization with more than 25 years of expertise in dermatology and rheumatology clinical research. Formerly known as Innovaderm, Indero delivers full-service clinical trial solutions, supporting sponsors across the entire drug development lifecycle—from protocol design and patient recruitment to monitoring and biometrics.
With operations spanning North America, Europe, Asia Pacific, and Latin America, Indero combines scientific rigor, global reach, and therapeutic specialization to help pharmaceutical and biotechnology partners deliver successful clinical outcomes at scale.
Role Overview
The Clinical Study Builder will collaborate closely with Data Management, Biostatistics, and Technology teams to design, configure, and deploy high-quality electronic case report forms (eCRFs), visit schedules, and data validation checks for clinical research studies. This role requires hands-on expertise in Medidata Rave CDMS and exposure to other EDC platforms such as Veeva and Medrio.
The position operates within a regulated clinical research environment and requires strict adherence to applicable regulatory requirements, industry guidelines, and internal standard operating procedures while meeting sponsor expectations and project timelines.
Key Responsibilities
Study Build and Configuration
Design, program, and configure eCRFs, folders, edit checks, derivations, integrations, migrations, and reports using Medidata Rave CDMS, Veeva EDC, and Medrio.
Build and configure Coder, Local Laboratory, and Targeted Source Data Verification (SDV) modules.
Lead eCRF design and review meetings with internal and external stakeholders.
Testing, Deployment, and Support
Execute system implementation, testing, and deployment activities for clinical studies.
Provide technical and end-user support throughout the study lifecycle.
Conduct end-user and stakeholder training on EDC system functionality.
Collaborate with vendor partners to support testing, integrations, and system releases.
Troubleshoot and resolve technical issues in a timely and compliant manner.
Process and Documentation
Work closely with Lead Data Managers to ensure alignment with protocol and data standards.
Participate in the development, review, and maintenance of Rave CDMS SOPs and procedural documentation.
Ensure all activities comply with GCP, ICH guidelines, and applicable regulatory requirements.
Required Qualifications and Experience
Education
Bachelor’s or Master’s degree (B.Sc. or M.Sc.) in Life Sciences, Pharmacy, Computer Science, or a related discipline.
Experience
Minimum 2 to 4 years of hands-on experience in Medidata Rave CDMS study build activities.
Proven experience supporting multiple study builds or post-production changes simultaneously.
Technical Knowledge and Skills
Certification as a Medidata Rave Study Builder is preferred.
Strong hands-on experience in Medidata Rave CDMS; exposure to Veeva EDC and Medrio is an advantage.
In-depth knowledge of eCRF design, database programming, and data validation processes.
Solid understanding of the clinical drug development lifecycle and regulatory frameworks, including GCP and ICH guidelines.
Excellent organizational, project planning, and time management skills.
Strong verbal and written communication skills in English.
Ability to work effectively in a fast-paced, deadline-driven environment with multiple competing priorities.
Work Environment and Benefits
Permanent, full-time position with a flexible work schedule.
Ongoing learning and professional development opportunities.
Collaborative and innovation-driven work culture focused on reliability and responsiveness.
Work Location
This is a home-based role in India. Availability for meetings outside regular business hours, primarily during evenings, is required to support global stakeholders.
Equal Opportunity Statement
Indero is committed to providing equal employment opportunities and equitable treatment to all individuals. Reasonable accommodations will be provided throughout the recruitment and selection process for applicants with disabilities, upon request.
Applicants must be legally eligible to work in India.
Apply Now
Build your career in Clinical Data Management by joining a global CRO recognized for scientific excellence, therapeutic expertise, and innovation in clinical research.
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Brazil | Sao paulo |Attica :
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