Job Description
Position: Clinical Research Manager – 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 strong 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 coordinators and site staff.
Required Qualifications
· Bachelor's/Master's degree in Life Sciences, Pharmacy, Nursing, Biotechnology, Clinical Research, or related field.
· Certification in Clinical Research will be an added advantage.
Experience
· 4–6 years of relevant Clinical Research experience in Neonatal Clinical Research..
· Mandatory hands-on experience in Neonatal Clinical Research.
· Proven experience in managing studies from start-up to study closure.
· Experience working with tertiary care hospitals, NICUs, or pediatric hospitals is preferred.
Required Skills
· Strong understanding of Clinical Trial Management.
· Thorough knowledge of ICH-GCP, CDSCO guidelines, and NDCT Rules.
· Experience with Ethics Committee and Regulatory submissions.
· Excellent documentation and report-writing skills.
· Strong stakeholder management and communication skills.
· Ability to manage multiple studies simultaneously.
· Good analytical and problem-solving abilities.
· Proficiency in Microsoft Office (Excel, Word, PowerPoint).
Preferred Candidate Profile
· Experience in Neonatal Intensive Care Unit (NICU)-based clinical studies.
· Exposure to investigator-initiated and sponsor-driven clinical trials.
· Experience in medical device or pharmaceutical clinical research will be an advantage.
· Willingness to travel for site visits and monitoring activities, if required.
Pay: ₹50,000.00 - ₹90,000.00 per month
Benefits:
- Paid sick time
- Paid time off
- Provident Fund
Application Question(s):
- How many years of experience do have in clinical research in Neonatology domain ?
Work Location: Hybrid remote in Delhi, Delhi (Delhi)
