Clinical Data Manager II- QC Specialist

Cytel; Pune District; On-site; INR 600,000 - 900,000; Full time

Job summary

Cytel is seeking a QC Specialist in Pune, India to plan, execute, and document testing activities for EDC and other systems. You will ensure builds meet specifications and support regulatory requirements for high-quality clinical trial data collection.

You will collaborate with Data Management, Database Development, and external partners to verify system readiness prior to study deployment and will contribute to risk-based testing and inspections readiness.

Qualifications

• Bachelor’s degree in Life Sciences, Computer Science, or related field.
• 2 years experience in clinical systems testing in regulated environments.
• Hands-on experience with Medidata Rave EDC.
• Strong understanding of clinical trial processes, data management workflows, and EDC build components.
• Working knowledge of GxP regulations and 21 CFR Part 11.
• Experience authoring and executing test scripts.
• Strong attention to detail, analytical thinking, and problem-solving.
• Excellent written and verbal communication skills.

Responsibilities

• Lead and execute testing activities ensuring systems are tested and fit for intended use prior to production release.
• Develop, review, and maintain test documentation, including test plans, test scripts, testing summary, and test data reports in accordance with SOPs and regulatory expectations.
• Design test scenarios to validate eCRF functionality, edit checks, integrations, data listings, data entry workflows, and reporting functionality.
• Execute testing, document results, identify defects, and collaborate with database developers to resolve issues.
• Review and assess the impact of EDC changes, amendments, and mid-study updates on testing status; support regression testing as required.
• Participate in risk-based testing activities, focusing testing efforts on critical data and high-risk functionality.
• Support testing of EDC releases and system updates, including assessment of vendor release notes and impact to existing studies.
• Ensure testing documentation is inspection-ready and supports internal audits and regulatory inspections.

Skills

Clinical systems testing

Medidata Rave EDC

GxP & 21 CFR Part 11

Test scripts execution

Regulatory compliance

Data management workflows

Education

Bachelor’s degree in Life Sciences or Computer Science

Job description

The QC Specialist is responsible for planning, executing, and documenting Testing activities for EDC and other systems. This role ensures that systems are tested and programmed to specification, supporting regulatory requirements and high-quality clinical trial data collection. The QC Specialist works closely with Data Management, Database Development, and external partners to verify that system builds meet specification expectations prior to study deployment. and programmed to specification, supporting regulatory requirements and high-quality clinical trial data collection, and external partners to verify that system builds meet specification expectations prior to study deployment.

• Lead and execute testing activities ensuring systems are tested and fit for intended use prior to production release.

• Develop, review, and maintain test documentation, including test plans, test scripts, testing summary, and test data reports in accordance with SOPs and regulatory expectations. test documentation, including test plans, test scripts, testing summary, and test data reports in accordance with SOPs and regulatory expectations.

• Design test scenarios to validate eCRF functionality, edit checks, integrations, data listings, data entry workflows, and reporting functionality.

• Execute testing, document results, identify defects, and collaborate with database developers to resolve issues.

• Review and assess the impact of EDC changes, amendments, and mid-study updates on testing status; support regression testing as required.

• Participate in risk-based testing activities, focusing testing efforts on critical data and high-risk functionality.

• Support testing of EDC releases and system updates, including assessment of vendor release notes and impact to existing studies.

• Ensure testing documentation is inspection-ready and supports internal audits and regulatory inspections.

Required Qualifications

• Bachelor’s degree in Life Sciences, Computer Science, or a related field.

• 2 years experience in clinical systems testing within a regulated environment testing within a regulated environment.

• Hands-on experience with Medidata Rave EDC.

• Strong understanding of clinical trial processes, 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.

• Strong attention to detail, analytical thinking, and problem-solving skills.

• Excellent written and verbal communication skills.

Preferred Qualifications

• Experience validating other Medidata applications (e.g., Coder, Safety Gateway, eCOA).

• Familiarity with Elluminate/CDS/CDP.

• Familiarity with risk-based testing approaches.

• Experience working with in-house Sponsor Data Management models.

• Prior involvement in regulatory inspections or audits related to clinical systems.

Cytel Inc. is an Equal Employment / Affymative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.