Job Summary

The Lead Clinical Data Manager is responsible for ensuring the accuracy, completeness and integrity of data collected during IVD clinical trials. The CDM is responsible for developing the clinical data management plan for pre-market and post-market clinical trials and timely execution of the plans throughout the lifecycle of the study.

This position reports to the Clinical Affairs Manager, Global QRC On-market Sustainment, and will be an in office role in Bengaluru.

Responsibilities

- Develop clinical study data management plans and provide clinical data management support for clinical teams, study projects, and biostatistics, including execution of data management plans across the full study lifecycle.
- Develop case report forms (or eCRF), clinical trial data specifications, EDC database specifications, user requirements, edit rules/checks, query logic and data validations.
- Define and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.

Requirements

- Bachelors or masters degree in science or health care area
- 5+ years of experience in developing and executing clinical data management procedures and thorough knowledge of clinical research.
- Experience with executing database lock,



freeze, close-out audits and archival activities for a clinical trial; manage external data transfers by developing data transfer agreements, reconciling electronic data transfers, generating data listings, validating summary tables, and preparing datasets for statistical review and audit readiness.
- Demonstrate proficiency with user acceptance testing following database upgrades or migrations, EDC user management across clinical trials, and creation of user guides for EDC training.
- Understand data system compliance by following the established guidelines of regulatory authorities.

Travel

- Occasional travel up to 25%

Desirable experience

- Experience in in-vitro diagnostics (IVD), Pathology, and Companion Diagnostics clinical research
- Demonstrated ability to explain complex or sensitive information to diverse audiences, including senior leaders; excellent organizational skills and ambition to continuously improve together with the business

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.

📌 Lead Clinical Data Manager, Global Quality (Karnataka)
🏢 DHR Holding India
📍 Karnataka