Medical Data Reviewer
il y a 1 semaine
Site Name:
Belgium-Wavre
Posted Date:
Jun
Job Purpose
The Medical Data Reviewer (MDR) collaborates with the Clinical Science Lead (CSL) for the execution of data management tasks requiring a scientific and medical input.
He/she is responsible for the scientific consistency and robustness of clinical data and ensures that the study data are complete and consistent from a medical perspective, under the accountability of the CSL.
Key Responsibilities
The main responsibility of the MDR is to ensure that the study data are complete, robust and consistent from a medical perspective.
- Responsible for the adequacy of the CRF and its consistency with the protocol
- Responsible for providing the patient profile specification and its validation
- Responsible for manual review of the data in close collaboration with the Clinical Data Reviewers and the CSL.
- Interact with Safety to ensure consistency between Safety and Clinical databases.
During the set-up phase:
- Provide input to electronic Case Report Form (eCRF) specifications and annotated Study Book.
- Provide input related to the medical data aspect in the development of eCRF completion guidelines.
- Ensure the capture of critical data linked to study endpoints from a medical data review perspective.
- Provide input into Data Cleaning strategy and Data cleaning technical requirements related to the medical data aspects.
- Provide business requirements for customization of the visualization/tracking tool used for medical data review as per study design requirements and performs UATs.
During study cleaning phase:
- Perform manual cleaning from medical perspective.
- Interact with Safety department to highlight inconsistencies between data reported.
- Support Stat check review.
- Escalate study risks related to medical review to study core team members.
During end of cleaning phase:
- Participate to preanalysis meetings.
- Support Stat check review.
- Support Filing of medical review documentation.
_ Why you?_:
Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Master's degree in life science, or equivalent acquired experience
- 35 years of experience in a disease area (academic or professional)
- Professional experience in medical review and/or Data Management including the setup and management of databases is an asset
- Organized, detaloriented, team player
- Fluent in English
#Li:
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive.
Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Our success absolutely depends on our people.While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.
We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy.
We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
**Important notice to Employment businesses/ Agencies-
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