Posted:20 hours ago|
Platform:
Work from Office
Full Time
The Manager Clinical Research is responsible for planning, designing, and managing clinical investigations for medical devices in accordance with CDSCO, EU MDR, ISO 14155, ICH-GCP, and NDCT-2019 requirements. The role ensures generation of high-quality clinical evidence to support product safety, performance, regulatory approvals, and post-market surveillance.
Key responsibilities include developing Clinical Evaluation Plans and study protocols, leading pre- and post-market clinical studies (including PMS and PMCF), managing investigators, sites, and CROs, ensuring compliance with global clinical and quality standards, supporting regulatory submissions, and collaborating with cross-functional teams throughout the product lifecycle
United Hr Solutions
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