Location: India (Remote – Pune, Maharashtra)
Job ID: 1491
Job Type: Full-Time
Experience Required: Minimum 2+ years (Not suitable for freshers)
About the Role
The Clinical Data Manager II – QC Specialist is responsible for planning, executing, and documenting system testing activities for Electronic Data Capture (EDC) and related clinical systems. This role plays a critical part in ensuring that clinical trial systems are validated, compliant with regulatory standards, and capable of capturing high-quality, reliable data.
The position involves close collaboration with Data Management, Database Development teams, and external vendors to ensure that system builds meet protocol specifications before study deployment.
Key Responsibilities
Lead and execute end-to-end testing activities to ensure systems are validated and production-ready
Develop, review, and maintain comprehensive testing documentation including test plans, test scripts, summary reports, and test datasets as per SOPs and regulatory requirements
Design and validate test scenarios covering eCRF functionality, edit checks, integrations, data listings, workflows, and reporting modules
Perform test execution, document results, identify defects, and coordinate with database developers for timely resolution
Evaluate the impact of protocol amendments, mid-study updates, and EDC changes; support regression testing activities
Implement risk-based testing approaches focusing on critical data points and high-risk functionalities
Support testing of EDC releases, system upgrades, and vendor updates, including impact assessment on ongoing studies
Ensure all testing documentation is audit-ready and compliant with internal and regulatory inspection standards
Required Qualifications
Bachelor’s degree in Life Sciences, Computer Science, or a related field
Minimum 2 years of experience in clinical systems testing within a regulated environment
Hands-on experience with Medidata Rave EDC
Strong understanding of clinical trial lifecycle, data management workflows, and EDC build processes
Working knowledge of GxP, 21 CFR Part 11, and software testing lifecycle
Experience in authoring and executing test scripts
Strong analytical skills, attention to detail, and problem-solving capabilities
Excellent written and verbal communication skills
Preferred Qualifications
Experience with additional Medidata platforms such as Coder, Safety Gateway, or eCOA
Familiarity with Elluminate, CDS, or CDP systems
Knowledge of risk-based testing methodologies
Experience working in sponsor-side or hybrid data management models
Exposure to regulatory audits and inspections related to clinical systems
Why This Role Matters
This position is essential in maintaining data integrity and regulatory compliance in clinical trials. As clinical research becomes increasingly data-driven, QC Specialists play a vital role in ensuring that EDC systems function accurately, supporting faster and safer drug development.
Important Note for Applicants
This role requires prior hands-on experience in EDC testing and clinical data management. Freshers are advised to begin with entry-level roles such as Clinical Data Coordinator, Junior Data Analyst, or Clinical Trial Assistant to build relevant experience before applying to this position.
How to Apply
Apply through the official company careers portal or explore verified global clinical research opportunities on ThePharmaDaily.com
Uttar Pradesh :
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