Medical Reviewer 549

ProductLife Group is looking for a Medical Reviewer to join our dynamic team on the following missions :

About us

Group 10
Responsibilities

  • Defines the medical review requirements for specific project or trial
  • Ensures the follow-up and update during the study (Medical concepts) in accordance with the  clinical study
  • Ensures the medical consistency of data during the whole study conduct
  • Manages e-mail alert, reviews the translated source documentation (e.g. hospital reports, lab records) from a medical point of view
  • Provides a direct medical support to the Monitors
  • participates in the Clinical Operations Project Managers/ Monitors and Investigators training meetings
  • Confirms the list of codes and the Global Safety (GS) rules to be used for the study
  • Analyzes the detected cases and have discussion on important medical events
  • Review of the protocol, IB, study training materials
  • Validates the protocol identified forbidden diseases and treatments to be followed by the Clinical Data Management Department (CDM)
  • Reviews the coding discrepancies between the Clinical and the GS databases before the reconciliation meeting
  • Provides medical expertise for the MDO in the coding activity
  • Participates in the safety / trialmeeting in order to define the risk indicators of the study
  • Reviews the blind review listings and participates in the blind review meeting
  • Guarantees the quality of the collaboration / communication of the project with the other structures
  • Represents the client for all questions of agencies / partners related to the MR scope of the project
  • Ensures consistency and homogeneity of MR activities within the project/trial
  • Provides regular reporting to their direct supervisor by providing consolidated information and proposals for solving problems
  • Is responsible for the constitution of the Sponsor Study File for MR activity scope
  • Provide training in therapeutic area, study indication, medical concept

Group 12
Education & Experience

  • Medical Doctor or MD degree
  • Experience in the following would be an advantage, such as Medical Review, clinical/research field , Medical Expertise , Global clinical trial, study related queries and safety reporting
  • Understanding of causality assessment and Coding.

 

Group 13
Skills

  • Ability to work cross functionally with a multi-site based team
  • Curiosity and investigation mindset
  • Good interpersonal and communication skills
  • Well organized
  • Ability to prioritize
  • Rigorous and ability to work in a team

Medical Reviewer 549