Lead Mdr - Wavre, België - GSK

GSK

Geverifieerd bedrijf

Wavre, België

2 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Site Name:
Belgium-Wavre

Posted Date:
Jul

Job Purpose

The Lead MDR is accountable within GSK Vx for the management of the medical review processes and systems supporting medical review tasks requiring a scientific/medical, process or technical/system input.

The Lead MDR collaborates with a large network from different departments within GSK and interact closely with the Clinical Project Lead (CPL), Clinical Science Lead (CSL), DS&M Data Management, Data Analytics, Safety, IT, GQA, Procurement, Study Delivery Management, Medical Review External Service provider(s) and other Medical Review teams within GSK (Oncology CTMRT).

Key Responsibilities

The Lead Medical Data Reviewer is
- responsible to lead the development and implementation of robust medical review processes for Vx Clinical Sciences including harmonization and standardization of ways of working
- the Vx representative in Global GSK medical review process/system initiatives
- responsible to define and ensure implementation of the Vx medical review business requirements related to new medical review visualization tools
- the Vx representatives in the Global medical review expert network and leads/manages the Vx medical review expert network
- responsible to manage, lead and implement adequate written standards (guidance, manual, templates,) and metrics/KPI's in order to ensure quality and oversight of medical review activities, scientific consistency and robustness of clinical data at all stages of the study from study setup, throughout the study conduct phase and until database freeze.

Responsible to create training material and provide medical review trainings. These trainings are either Global GSK or Vx specific medical review trainings and are provide in the context of onboarding of newcomers or maintenance of medical review expertise.
Responsible for vendor business oversight of external medical review service provider(s)
Responsible for the escalation of medical review related risks
Manages the medical data review planning and is responsible for the medical data review resource requirements
Responsible to support audit/inspection preparation activities and is responsible to act as fronter for medical review general process/system related topics.
On top of the abovementioned activities, the Lead Medical Data Reviewer is considered to be a senior and expert in performing medical data review during study setup, cleaning and closure activities.

_ __Why you?_**:

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

Master's degree in life science, or equivalent acquired experience
5 years of experience in a disease area (academic or professional)
Professional experience in Data Management including the setup and management of databases will be an asset
Leadership skills
Organized
Detailoriented but with ability to keep holistic view and summarize
Good business understanding
Stakeholder management skills
Process & system oriented
Fluent in English writing & speaking
Experience translating clinical protocols into technical specifications
Experience managing data quality, safety, risk management & regulatory guidelines

Preferred Qualifications:

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

Master's degree in life science

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