Job Description About the Role:

We are looking for a Clinical Data Manager (CDM) with 5 7 years of experience in end-to-end Clinical Data Management activities. The ideal candidate will have strong expertise in eCRF design, UAT testing, data cleaning, discrepancy management, and data reconciliation, along with a deep understanding of clinical trial processes. This role offers an excellent prospect to work on cutting-edge tools and technologies while ensuring data accuracy and quality in clinical trials.

Key Responsibilities:

- Manage end-to-end Clinical Data Management (Start-up, Conduct Close) activities.

- Define project specifications for Database Build, CRF Design, Data Review, and Reconciliation Tools.

- Execute data cleaning strategies and maintain subject data cleanliness for timely deliverables.

- Perform query management, discrepancy management, and external data reconciliation.

- Review protocols and participate in UAT testing to ensure database accuracy.

- Conduct holistic data review and analytics using platforms such as elluminate Data Central.

- Utilize AI/ML tools for anomaly detection and data quality improvement.

- Monitor and interpret KPIs, metrics, dashboards, and Clinical Trial Operational Analytics (CTOA).

- Prepare and maintain Data Management documentation (DMP, CCGs, DVS, Help Texts).

- Ensure quality control of deliverables including eCRFs, study documents, and reports.





- Collaborate with cross-functional teams to meet project timelines and quality standards.

- Ensure compliance with ICH/GCP, 21 CFR Part 11, and industry best practices.

Candidate Profile:

Education Experience:

- Bachelor s degree in a Health or Life Sciences field (or equivalent experience).

- Minimum 5+ years of experience in Clinical Data Management.

- CCDM Certification preferred.

Professional Skills:

- Strong project management and leadership capabilities.

- Excellent analytical, strategic thinking, and problem-solving skills.

- Highly detail-oriented with strong organizational skills.

- Effective communication and teamwork abilities.

- Proficient in English (verbal and written).

Technical Skills:

- Proficient in EDC and Clinical Data Management Systems.

- Strong knowledge of Microsoft Excel and MS Project.

- Familiarity with ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodologies.

- Exposure to Cloud SaaS platforms and data visualization tools (Qlik, JReview, Spotfire).

- Experience with RBQM methodology and CDISC standards preferred.

Mandatory Skills:

End-to-End CDM Activities | eCRF | Protocol Review | UAT Testing | Data Cleaning | Discrepancy Management | Reconciliation

Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Clinical Data Manager (Karnataka)
🏢 Gigaops Global Solutions
📍 Karnataka