Cytel Inc. is seeking candidates for the position of Clinical Data Manager II – QC Specialist for a full-time remote role in India. The position focuses on quality control testing of Electronic Data Capture (EDC) systems and other clinical systems to ensure they meet specifications, support regulatory requirements, and enable high-quality clinical trial data collection.
Candidates with experience in clinical systems testing, Medidata Rave EDC, clinical data management workflows, and regulated environments can explore this opportunity.
Job Details
| Particulars | Details |
|---|---|
| Company | Cytel Inc. |
| Job Title | Clinical Data Manager II – QC Specialist |
| Job Identification | 1874 |
| Job Category | Clinical Data Insights & Analytics |
| Job Location | Remote, Pune, Maharashtra, India |
| Work Mode | Remote |
| Job Type | Full-time |
| Experience | 2 years in clinical systems testing |
| Qualification | Bachelor’s degree in Life Sciences, Computer Science, or a related field |
| Posting Date | 23 October 2026 |
Position
Clinical Data Manager II – QC Specialist
The role involves planning, executing, and documenting testing activities for EDC and other clinical systems. The QC Specialist works with Data Management, Database Development, and external partners to verify that system builds meet specifications before study deployment.
Job Responsibilities
- Lead and execute testing activities to confirm that clinical systems are fit for intended use before production release.
- Develop, review, and maintain test plans, test scripts, testing summaries, and test data reports in accordance with SOPs and regulatory expectations.
- Design test scenarios for eCRF functionality, edit checks, integrations, data listings, data entry workflows, and reporting functionality.
- Execute tests, document results, identify defects, and collaborate with database developers to resolve issues.
- Assess the impact of EDC changes, amendments, and mid-study updates on testing status.
- Support regression testing when required.
- Participate in risk-based testing, prioritizing critical data and high-risk functionality.
- Test EDC releases and system updates, including assessing vendor release notes and their impact on existing studies.
- Maintain inspection-ready testing documentation to support internal audits and regulatory inspections.
Eligibility and Qualifications
Candidates must meet the following requirements:
- Education: Bachelor’s degree in Life Sciences, Computer Science, or a related field.
- Experience: At least two years of experience in clinical systems testing within a regulated environment.
- Hands-on experience with Medidata Rave EDC.
- Strong understanding of clinical trial processes, clinical data management workflows, and EDC build components.
- Working knowledge of GxP regulations, 21 CFR Part 11, and testing lifecycle concepts.
- Experience authoring and executing test scripts.
Preferred Qualifications
- Experience validating other Medidata applications, such as Coder, Safety Gateway, and eCOA.
- Familiarity with Elluminate, CDS, or CDP.
- Familiarity with risk-based testing approaches.
- Experience with in-house Sponsor Data Management models.
- Previous involvement in regulatory inspections or audits related to clinical systems.
Required Skills
- Clinical systems quality control and testing.
- Medidata Rave EDC.
- Test planning, test script development, and test execution.
- EDC build validation and regression testing.
- Clinical trial and data management workflows.
- Knowledge of GxP regulations and 21 CFR Part 11.
- Analytical thinking, attention to detail, and problem-solving.
- Strong written and verbal communication skills.
