Open Opportunities
Medical Reviewer 549
Medical Reviewer 549
ProductLife Group is looking for a Medical Reviewer to join our dynamic team on the following missions :
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
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.
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
Publish Date
07 June, 2022
Spontaneous Application
Medical Reviewer 549
New opportunities open up across PLG all the time. If nothing matches right now, send us a spontaneous application: we will keep you in mind for what comes next.