Medical Expert

Novumgen; Vadodara; On-site; INR 300,000 - 540,000; Full time

Job summary

Novumgen is seeking a Medical Expert for its Clinical Affairs team. The role supports conducting clinical studies, reviews participant histories and lab results, and ensures adherence to protocol, SOPs and ICH-GCP.

Fresher MBBS graduates will contribute to safety monitoring, adverse event assessment, medical input during screening, procedures, follow-up and discharge, with training and growth opportunities within the sponsor's CLINICAL AFFAIRS division.

Qualifications

• MBBS degree required.
• Fresher with interest in clinical research.

Responsibilities

• Provide medical support during the conduct of clinical studies as assigned.
• Review participant medical history, clinical findings, physical examination findings, and relevant laboratory/diagnostic results.
• Support assessment of participant eligibility based on protocol-defined criteria.
• Identify clinically significant abnormal findings and recommend appropriate medical follow-up.
• Monitor participants for adverse events, clinical symptoms, and other safety concerns.
• Review and document adverse events and provide appropriate medical assessment as per applicable procedures.
• Immediately escalation serious, unexpected, or clinically significant safety concerns to the Principal Investigator/Medical Lead.
• Support appropriate medical management and referral of participants when required.
• Provide medical input during participant screening, study procedures, follow-up, and discharge, as applicable to the study.
• Review relevant source documents and clinical records for completeness, accuracy, consistency, and appropriate medical documentation.
• Support review of protocol deviations involving medical or participant-safety aspects.
• Review protocols, amendments, and study-specific documents from a medical perspective, as assigned.
• Provide medical input for informed consent documents and participant information materials, where required.
• Participate in protocol, GCP, SOP, and study-specific training.
• Ensure that assigned activities are performed in accordance with the approved protocol, SOPs, ICH-GCP, applicable regulatory requirements, and ethical principles.
• Maintain confidentiality of participant medical information and study-related information.
• Maintain accurate, contemporaneous, and traceable documentation of medical assessments and decisions.
• Participate in internal audits, sponsor audits, and regulatory inspections as required.
• Maintain current knowledge of GCP, clinical research requirements, and relevant medical guidelines.

Education

MBBS

Job description

Job Description

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 escalation serious, 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.