Medical Monitor

Eligibility Criteria:

Indian institutes

Medical Registration Certificate

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

Freshers

📍 Location: Miyapur, Hyderabad

💼 Role: Medical Monitor

🕒 Work Mode: WFO (Full Time)

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

Role Description

This is a full-time on-site role for a Medical Monitor, located in Hyderabad. The Medical Monitor will be responsible for overseeing clinical trials, ensuring compliance with regulatory requirements, managing patient safety, reviewing study data, and collaborating with cross-functional teams. The role involves preparing and reviewing medical documents, supporting medical writing activities, and participating in regulatory submissions and audits.

Company Description:

AXIS Clinicals Limited is one of the most experienced and fastest growing Clinical Research Organizations. Our state-of-the-art facilities house over 500 dedicated full-time professionals to ensure quick turnaround times with high quality. Accredited by DCGI, NABL, and inspected by global authorities such as US-FDA, UK-MHRA, and others, we have completed 2750+ clinical studies and achieved 1000+ product approvals. Our expanding Phase II – IV capabilities are complemented by Site Management, Medical Writing, and Data Management services.