Cytel Inc. is listed as hiring for the position of Clinical Data Manager II – QC Specialist for a full-time remote opportunity in India. This role is suitable for professionals with experience in clinical systems testing, electronic data capture (EDC), and clinical data management within regulated environments.
The selected candidate will help ensure that clinical systems are tested thoroughly before deployment. Key responsibilities include preparing test plans and scripts, validating electronic case report forms (eCRFs), identifying system defects, conducting regression testing, and maintaining documentation for audits and regulatory inspections.
Candidates with a relevant bachelor’s degree, at least two years of clinical systems testing experience, and hands-on knowledge of Medidata Rave EDC can review the eligibility requirements below.
Cytel Recruitment 2026: Job Highlights
| Particulars | Details |
|---|---|
| Company | Cytel Inc. |
| Job Title | Clinical Data Manager II – QC Specialist |
| Job Identification | 1874 |
| Department / Category | Clinical Data Insights & Analytics |
| Job Location | Remote, Pune, Maharashtra, India |
| Work Mode | Remote |
| Employment Type | Full-time |
| Experience Required | At least 2 years in clinical systems testing |
| Qualification | Bachelor’s degree in Life Sciences, Computer Science, or a related field |
| Key Platform | Medidata Rave EDC |
| Job Posting Date | October 23, 2026 |
| Third-Party Listing Date | October 25, 2026 |
| Salary | Not disclosed |
| Application Mode | Online |
About Cytel Inc.
Cytel is a company associated with biostatistics, clinical research, and statistical innovation for the life sciences industry. The advertised position falls within Clinical Data Insights & Analytics and focuses on quality control testing of clinical systems.
The role involves collaboration with data management professionals, database developers, and external partners to ensure that clinical systems operate according to approved specifications and support reliable clinical trial data collection.
Job Description: Clinical Data Manager II – QC Specialist
The Clinical Data Manager II – QC Specialist will plan, execute, and document quality control testing for electronic data capture systems and other clinical applications.
The position requires a strong understanding of clinical trial workflows, EDC system configurations, testing documentation, and applicable regulatory expectations. The successful candidate will evaluate system functionality, document test results, communicate defects, and help confirm that changes do not negatively affect existing studies.
Maintaining accurate, traceable, and inspection-ready documentation is also an important part of the role.
Key Responsibilities
1. Clinical Systems Testing
- Plan and execute testing activities to verify that clinical systems are fit for their intended use before production release.
- Check system functionality against approved specifications.
- Identify issues and document testing outcomes.
- Collaborate with database developers to investigate and resolve defects.
2. Test Plans and Documentation
- Develop, review, and maintain test plans, test scripts, testing summaries, and test data reports.
- Follow applicable standard operating procedures (SOPs) and regulatory expectations.
- Ensure testing evidence is complete, accurate, and traceable.
- Maintain documentation suitable for internal audits and regulatory inspections.
3. EDC and eCRF Validation
- Design test scenarios for electronic case report forms (eCRFs).
- Validate edit checks, integrations, data listings, data entry workflows, and reporting functionality.
- Verify that EDC system configurations work according to the specified requirements.
- Record defects and communicate findings to relevant technical teams.
4. Defect Management and Regression Testing
- Execute test scripts and document test results.
- Identify defects and work with database developers to support resolution.
- Assess how EDC changes, protocol amendments, and mid-study updates affect testing requirements.
- Conduct regression testing when required to confirm that updates have not disrupted existing functionality.
5. Risk-Based Testing
- Participate in risk-based testing activities.
- Prioritise testing of critical data and high-risk system functions.
- Support testing decisions based on the potential impact of system failures on clinical trial data quality.
6. EDC Releases and System Updates
- Support testing of EDC releases and clinical system updates.
- Review vendor release notes and evaluate their potential impact on ongoing studies.
- Identify additional testing requirements associated with system changes.
- Coordinate with relevant stakeholders to support reliable system deployment.
7. Regulatory Compliance and Audit Readiness
- Maintain testing documentation in accordance with SOPs and applicable regulatory expectations.
- Support compliance with relevant GxP requirements and 21 CFR Part 11.
- Keep test records organised and ready for inspection.
- Support internal audit and regulatory inspection activities related to clinical systems.
Eligibility Criteria
Educational Qualification
Candidates must have a bachelor’s degree in Life Sciences, Computer Science, or a related field.
Relevant educational backgrounds may include:
- B.Sc. in Life Sciences
- M.Sc. in Life Sciences
- B.Sc. in Computer Science
- M.Sc. in Computer Science
- B.Pharm
- M.Pharm
- A bachelor’s degree in a related discipline
The third-party vacancy listing includes these examples, while the supplied job description states a bachelor’s degree in Life Sciences, Computer Science, or a related field. Candidates should confirm whether their specific qualification meets the employer’s requirements.
Work Experience
Applicants need at least two years of experience in clinical systems testing within a regulated environment.
Experience with clinical applications, EDC configuration testing, test script execution, and clinical data management workflows is particularly relevant.
Mandatory Technical Skills
The listed requirements include:
- Hands-on experience with Medidata Rave EDC.
- Understanding of clinical trial processes.
- Knowledge of clinical data management workflows.
- Familiarity with EDC build components.
- Working knowledge of GxP regulations.
- Understanding of 21 CFR Part 11.
- Knowledge of the clinical systems testing lifecycle.
- Experience writing and executing test scripts.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication.
Important: Medidata Rave EDC experience is specifically identified as a requirement. Applicants should carefully review this criterion before submitting their applications.
Preferred Qualifications
The following experience may strengthen a candidate’s suitability for the position:
- Validation of additional Medidata applications, including Coder, Safety Gateway, and eCOA.
- Familiarity with Elluminate, CDS, or CDP.
- Experience with risk-based testing methodologies.
- Experience working with in-house sponsor data management models.
- Involvement in regulatory inspections or audits related to clinical systems.
These are listed as preferred qualifications and should be distinguished from the mandatory requirements.
Key Technical Concepts for Applicants
Medidata Rave EDC
Medidata Rave EDC is an electronic data capture platform used in clinical research to collect and manage clinical trial data. In this position, testing may involve checking eCRFs, edit checks, data workflows, integrations, and reporting functions against approved specifications.
GxP Compliance
GxP refers to a group of quality guidelines and regulations used across regulated industries. In clinical research, applicable GxP requirements help support data integrity, reliable processes, and appropriate documentation.
21 CFR Part 11
21 CFR Part 11 is a US FDA regulation covering electronic records and electronic signatures under specified conditions. Familiarity with the regulation is relevant to professionals involved in clinical system validation and compliance.
Job Location and Work Mode
The position is advertised as a remote job in India, with Pune, Maharashtra, included in the location details.
| Work Detail | Information |
|---|---|
| Country | India |
| Location Reference | Pune, Maharashtra |
| Work Arrangement | Remote |
| Employment Schedule | Full-time |
Candidates should confirm any geographical eligibility requirements, office attendance expectations, or other remote-work conditions on the employer’s application page.
Salary and Benefits
The salary for this Clinical Data Manager II – QC Specialist position has not been disclosed in the supplied vacancy details.
Specific information about bonuses, insurance, paid leave, equipment allowances, and other employee benefits was also not provided. Candidates can check the original vacancy page or contact the employer for compensation and benefits information.
How to Apply for Cytel Recruitment 2026
Interested candidates can apply through the online application link provided on the original vacancy listing.
Application steps:
- Open the original recruitment listing for the Clinical Data Manager II – QC Specialist position.
- Follow its “How to Apply” or “Apply Now” link.
- Verify the employer, job identification number 1874, and remote-work location.
- Review the eligibility requirements, particularly Medidata Rave EDC and clinical systems testing experience.
- Submit your updated resume and complete the application form through the employer’s recruitment portal.
This link leads to the third-party listing, not directly to the employer’s application form. Confirm the destination and vacancy details before submitting your information.
Frequently Asked Questions (FAQs)
1. What is the job title at Cytel?
The vacancy is listed as Clinical Data Manager II – QC Specialist.
2. Where is the job located?
The position is advertised as remote in India, with Pune, Maharashtra, appearing in the location details.
3. What is the job identification number?
The job identification number is 1874.
4. How much experience is required?
Candidates need at least two years of clinical systems testing experience in a regulated environment.
5. Which qualifications are accepted?
The job description requires a bachelor’s degree in Life Sciences, Computer Science, or a related field. The third-party listing also identifies examples such as B.Sc., M.Sc., B.Pharm, and M.Pharm.
6. Is Medidata Rave EDC experience required?
Yes. Hands-on experience with Medidata Rave EDC is explicitly listed as a required qualification.
7. What are the main responsibilities?
Responsibilities include EDC testing, test script development and execution, eCRF validation, defect management, regression testing, risk-based testing, and maintaining inspection-ready documentation.
8. What is the salary for this position?
The salary has not been disclosed in the available vacancy information.
9. Is this a full-time role?
Yes. The vacancy is listed as full-time.
10. What are the preferred additional skills?
Experience with other Medidata applications, familiarity with Elluminate/CDS/CDP, risk-based testing, sponsor data management models, and regulatory audits are listed as preferred.
11. How can I apply for this job?
Visit the original Cytel vacancy listing and follow the application instructions to reach the employer’s recruitment portal.
Disclaimer
This article is based on a third-party vacancy listing published on October 25, 2026, and the supplied job description for Cytel Inc. The vacancy status, salary, benefits, application deadline, and remote-work conditions were not independently verified. Candidates should confirm all details through the employer’s official recruitment portal before applying.