Medical Monitor - (Indian Registered MBBS Candidates only)

Eligibility Criteria:

• MBBS graduates only from Indian institutes• Must hold a valid Medical Registration Certificate

• Willing to Work with us for At least 3-4 Years

Responsibilities:

• Provide protocol and therapeutic area training to study teams (both internal and external).
• Provide response to PI/site/EC queries.
• Prepare medical monitoring plan
• Review of Protocol deviation and Categorization of the same.
• CSR/SMP/SAP review
• Review study enrolled subject reports for eligibility in coordination with Project Manager/Designee, if required.
• SAE management if any, follow up with sites/ investigator for SAE updates and updating sponsor accordingly.
• Review and develop amendments (if required) to Protocol and other study documents such as Safety Monitoring Plan, expedited reporting plans, eligibility review plan.
• Liaison with investigators and sponsor medical monitor for any medical queries.
• Responsible for review of AE and SAE data in the clinical trial for its completeness and accuracy
• Responsible for review of SAE forms received from Sites.
• To communicate various safety related aspects with the stake holders i.e., Study team to site, safety management team and various regulatory agencies and Sponsors team.
• Responsible for preparation of SAE reporting Data Elements for Reporting Serious Adverse Events Occurring in A Clinical Trial or Bioavailability or Bioequivalence Study.
• Review the prepared draft safety reports (CIOMs, SUSAR, 6MLL and DSURs) and provide the comments/suggestion/recommendation on the same.
• Responsible for coordination with internal Regulatory and operation team for completion of SAE forms.
• Responsible for ensuring electronic reporting of SAEs to DCGI, Chairman of Ethics Committees and Head of Institutions within stipulated timelines.
• Responsible for review of individual case narratives.
• Responsible review of the prepared draft CSR.
• AE, Concomitant Medication, Medical History, Vital signs, Physical examination, I/E listing review.
• Review the blinded study data on regular periodic basis