JOB POST: Senior Medical Monitor at Biorasi [Remote]: Apply Now!

Biorasi is looking for top performers who are as passionate about clinical research as we are – clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients.

About Biorasi

Biorasi is a customer-focused, full-service, contract research organization that delivers fast and flexible solutions across global clinical trials to maximize speed-to-market for its sponsors.

Education Qualification

  • Medical degree, MD, DO or its international equivalent.
  • 2-5 years’ experience within the pharmaceutical industry or related field
  • Must have previous Medical Monitor experience in oncology/neurology. Cell and/or gene therapy is desirable.
  • Keen knowledge and thorough understanding of ICH GCP and applicable regulatory requirements.
  • Strong written and verbal communication, presentation skills, and professional English language level
  • Critical Thinking and background medical and scientific research
  • Strong proficiency in using Microsoft Office
  • Experience with safety databases (ARISg, Oracle Argus, etc.) and/or EDC system (IBM, Medrio, Medidata) a plus

Job Role

  • Act as a study Primary Medical Monitor for the assigned clinical studies.
  • Be a Medical expert and readily available to investigator, site, and study team to advise on medical related questions.
  • Provide Sites with the knowledge to properly evaluate subjects and adhere to the protocol.
  • Responsible for providing protocol training to the study team, as needed.
  • Lead in medical review, assessment, and interpretation of clinical and safety data to ensure that the data are correct and presented with the appropriate medical interpretation.
  • Escalate any critical safety concerns to the study team and Sponsor, and coordinate between sites and study team/Sponsor.
  • Prepare case studies and lead the DMC meetings and Sponsor calls.
  • Work closely with Safety and Pharmacovigilance team to provide medical input into safety reports including, SAE narratives and analysis of similar events, Development Safety Update Reports (DSURs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) reports, and Company Core Safety Information (CCSI), etc.
  • Responsible for the review of individual data with SAEs and potentially clinically important laboratory test results or vital sign abnormalities and escalate issues to the Sponsor as needed.
  • Assist in medical and scientific review of deliverables such as TLFs and CSR.
  • Assist in the design and conduct of clinical trials including the development of first draft and review of protocols and amendments.
  • Follow international GCP guidelines/regulations and SOPs for executing clinical studies.
  • Lead in developing and maintaining SOPs, Templates, and study plans
  • Assist in Medical Monitoring related Audit activities that may occur.
  • Train and mentor new personnel within the branch
  • Perform other duties for the Medical & Scientific Affairs branch, as assigned

Job Location

This is a remote based position located anywhere within India.

Click here to apply for the post of Senior Medical Monitor at Biorasi

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