Biorasi Hiring Senior, MSA (Medical Monitor)

Biorasi Hiring Senior, MSA (Medical Monitor)

23 April, 2022

Overview

  • Biorasi is an innovative and fast-growing global CRO that provides a full range of services.
  • Our work culture includes: teamwork, hands-on mentality, flexibility, and open communication.
  • In this position, you will manage or support all clinical aspects of a study, including assessing operational feasibility; assist in managing Clinical study timelines and metrics; provides study-specific training and leadership to clinical team; prepares and presents project debriefings, as required; plan, execute, lead or support study-specific meetings (e.g., Study Management Meetings, investigator meetings).

.Job Responsibilities

  • 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.

Ideal Background

  • Medical degree, MD, DO or its international equivalent.
  • 2-5 years’ experience within the pharmaceutical industry or related field
  • 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

Apply through this Link

Leave a Reply

Your email address will not be published. Required fields are marked *