Role & Responsibilities

The Medical Monitor will perform the following duties:

Project related duties include:

1. Patient Safety Oversight which involves:

• Regularly analyzes adverse events, identifies serious adverse events, and ensures proper follow-up until recovery.
• Communicates findings to stakeholders (investigators, regulatory bodies) to ensure patient safety.
• Provides medical advice and guidance to the study team and investigators regarding patient safety concerns.

2. Protocol Review and Development:

• Reviews and evaluates information relevant to product safety throughout the development and implementation of the protocol.
• Provides input on protocol design, including study halting rules, and safety guidelines.
• May suggest protocol modifications to prevent or manage adverse events.

3. Medical Data Review and Interpretation:

• Reviews patient data from a safety perspective.
• Participates in data review and interpretation, contributing to the overall understanding of the study results.

4. Communication and Collaboration:

• Serves as a medical consultant to the project team, providing medical and therapeutic area expertise.
• Interacts with site investigators to provide them with information on the study product and address medical questions.
• Attends and participates in investigator meetings.

5. Regulatory Compliance:

• Ensures that the trial is conducted in accordance with Good Clinical Practice (GCP) guidelines and regulatory requirements.
• Provides input on regulatory documents and submissions.

6. Other responsibilities:

• Review SAE and potential SUSAR.
• Medical training and medical support
• Patient eligibility review

7. Work closely with the Clinical Operations team for the assessment of Serious Adverse Events.
8. Liaison with the Sponsor Medical Expert
9. Writing SOPs for Medical Monitoring, Safety Management Medical Review etc.
10. Any other tasks that are assigned from time to time.
11. Willing to travel for job related tasks as identified from time to time.

Non-Project Related duties

1. Prepare SOPs
2. Prepare training materials.
3. Interface with clients, sites and investigators when required.

Participate in business meetings and make presentations when required.

5. Accomplish jobs assigned from time to time to meet satisfaction of the management.
6. Work in alignment with the company objectives and common goal of the company.