Medical Monitor
Medical Monitor
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Job Description
We are seeking a highly skilled and experienced Medical Monitor to join our clinical research team in Hyderabad India. As a Medical Monitor you will play a crucial role in ensuring the safety and integrity of our clinical trials providing medical expertise throughout the study lifecycle.
- Oversee the medical aspects of clinical trials including protocol development study conduct and data interpretation
- Review and assess safety data adverse events and serious adverse events in ongoing clinical trials
- Provide medical expertise in the development and review of study protocols informed consent forms and clinical study reports
Advise project teams sites data safety monitoring boards regulatory agencies and third-party vendors on medical matters
Collaborate with cross-functional teams to address medical and safety issues arising during clinical trials
Identify Program risks and create and implement mitigation strategies with Clinical Operations
- Participate in the development of risk management plans and safety monitoring strategies
- Conduct medical review of clinical data and contribute to the preparation of clinical study reports
- Serve as a medical resource for study teams investigators and other stakeholders
- Ensure compliance with ICH-GCP guidelines regulatory requirements and internal SOPs
- Contribute to the development of investigator brochures and other clinical documents
- Represent the company in interactions with regulatory authorities and ethics committees as needed
Qualifications :
Qualifications and experience
- MBBS MD (Pharmacology)
- Minimum 3 years of experience as Medical Monitor
Job role requirements
- Thorough understanding of ICH-GCP guidelines and regulatory requirements in clinical research
- Proven experience in conducting and/or monitoring clinical trials
- Strong knowledge of the drug development process
- Excellent skills in medical data analysis and interpretation
- Proficiency in protocol development and review
- Experience in adverse event assessment and management
- Strong medical writing skills for creating and reviewing clinical documents
- Proficiency in using clinical trial management systems
- Outstanding communication and interpersonal skills with the ability to interact effectively with diverse stakeholders
- Detail-oriented with strong analytical and problem-solving abilities
- Ability to work efficiently in a fast-paced dynamic environment
- Willingness to travel as required for the role
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
