AXIS Clinicals Ltd

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 • Freshers & Experienced candidates are welcome 📍 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.