Position Title- Medical Expert

Department- Clinical Affairs

Experience Requirement: Fresher

Qualification Requirement: MBBS

Profile Requirements:

1. Provide medical support during the conduct of clinical studies as assigned.
2. Review participant medical history, clinical findings, physical examination findings, and relevant laboratory/diagnostic results.
3. Support assessment of participant eligibility based on protocol-defined criteria.
4. Identify clinically significant abnormal findings and recommend appropriate medical follow-up.
5. Monitor participants for adverse events, clinical symptoms, and other safety concerns.
6. Review and document adverse events and provide appropriate medical assessment as per applicable procedures.
7. Immediately escalate responsible, unexpected, or clinically significant safety concerns to the Principal Investigator/Medical Lead.
8. Support appropriate medical management and referral of participants when required.
9. Provide medical input during participant screening, study procedures, follow-up, and discharge, as applicable to the study.
10. Review relevant source documents and clinical records for completeness,



accuracy, consistency, and appropriate medical documentation.
11. Support review of protocol deviations involving medical or participant-safety aspects.
12. Review protocols, amendments, and study-specific documents from a medical perspective, as assigned.
13. Provide medical input for informed consent documents and participant information materials, where required.
14. Participate in protocol, GCP, SOP, and study-specific training.
15. Ensure that assigned activities are performed in accordance with the approved protocol, SOPs, ICH-GCP, applicable regulatory requirements, and ethical principles.
16. Maintain confidentiality of participant medical information and study-related information.
17. Maintain accurate, contemporaneous, and traceable documentation of medical assessments and decisions.
18. Participate in internal audits, sponsor audits, and regulatory inspections as required.
19. Maintain current knowledge of GCP, clinical research requirements, and relevant medical guidelines.

📌 Medical Expert (Vadodara)
🏢 Novumgen
📍 Vadodara