Clinical Data Manager II – QC Specialist

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🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 25%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Clinical Outcomes Solutions

WebsiteLinkedInAll Job Openings

51 - 200 employees

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

Clinical Outcomes Solutions is a global clinical outcomes consultancy that provides comprehensive support and services in all aspects of Clinical Outcome Assessment (COA) research. The company helps inform patient care by capturing the patient voice through innovative scientific methods. It guides organizations in navigating the complexities of clinical outcomes research by crafting strategies and solutions to capture accurate data. Trusted by pharmaceutical and biotechnology companies, the firm ensures regulatory compliance and optimized patient outcomes.

📋 Description

• 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

🎯 Requirements

• Bachelor’s degree in Life Sciences, Computer Science, or a related field • 2 years experience in clinical systems 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: Experience validating other Medidata applications (e.g., Coder, Safety Gateway, eCOA) • Preferred: Familiarity with Elluminate/CDS/CDP • Preferred: Familiarity with risk-based testing approaches • Preferred: Experience working with in-house Sponsor Data Management models • Preferred: Prior involvement in regulatory inspections or audits related to clinical systems