Manager, Medical Data Reviewer

il y a 2 semaines

Wavre, Belgique GSK Temps plein

**Site Name**: Belgium-Wavre
**Posted Date**: Dec 4 2024

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.

He/she is responsible for the scientific consistency and robustness of clinical data of the study from study setup, throughout the study conduct phase and until database freeze:

- 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.

The job encompasses, but is not limited to the following tasks:
During the set-up phase:

- Provide input to electronic Case Report Form (e-CRF) 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 pre-analysis meetings.
- Support Stat check review.
- Support Filing of medical review documentation.

**_ Why you?_**:
**Basic Qualifications**:
We are looking for professionals with these required skills to achieve our goals:

- Master degree in life science, or equivalent acquired experience
- 3 - 5 years of experience in a disease area (academic or professional)
- Professional experience in medical review and/or Data Management including the set-up and management of databases is an asset.
- Organized
- Detail-oriented
- Business understanding
- Team player- Fluent in English

**Preferred Qualifications**:
If you have the following characteristics, it would be a plus:

- Master degree in life science in one of the following area: life sciences or Biomedical Sciences or Clinical Research

**#Li-GSK**:
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.

**Why GSK?**

**Uniting science, technology and talent to get ahead of disease together.**

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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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