Clinical Research (India)

Clinical Research (India)

12 Aug
|
Thermaissance
|
India

12 Aug

Thermaissance

India

Job Description
Position: Clinical Research – Neonatology
Location: Delhi (Preferred) / Bengaluru
Department: Clinical Research
Experience: 4–6 Years (Mandatory experience in Neonatal Clinical Research)

About Thermaissance
Thermaissance is a healthcare innovation company developing advanced medical textile solutions for NICUs, ICUs, and hospitals . Our CE-certified medical devices help improve infection prevention, thermal stability, and patient comfort. We work closely with leading clinicians and hospitals to generate clinical evidence that advances neonatal and critical care.

About the Role
We are looking for an experienced Clinical Research professional with solid expertise in Neonatal Clinical Research to manage and execute clinical studies from initiation to completion. The ideal candidate should have hands-on experience in end-to-end clinical trial management, regulatory compliance, and coordination with investigators, hospitals, ethics committees, and sponsors.
Key Responsibilities
- Manage end-to-end clinical research projects in the neonatal therapeutic area.




- Coordinate study start-up activities, including site selection, feasibility, ethics committee submissions, and regulatory documentation.
- Develop and maintain study-related documentation such as protocols, informed consent forms, CRFs, and study manuals.
- Ensure compliance with ICH-GCP, CDSCO, NDCT Rules, and applicable regulatory guidelines.
- Coordinate with investigators, hospitals, CROs, sponsors, and internal stakeholders throughout the study lifecycle.
- Monitor study progress, patient recruitment, data quality, protocol adherence, and timelines.
- Manage safety reporting, adverse events (AEs/SAEs), and regulatory submissions.
- Review clinical data for completeness and accuracy while ensuring data integrity.
- Prepare study reports, monitoring reports, and clinical documentation.
- Support audits, inspections, and quality assurance activities.
- Provide training and guidance to study coor

📌 Clinical Research (India)
🏢 Thermaissance
📍 India

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