Medical Data Reviewer

Job description

Details:
Job Purpose:

The Medical Data Reviewer (MDR) collaborates with the Clinical Research and Development Lead (CRDL) or the Epidemiology lead for the execution of Data Management tasks requiring a scientific and medical input.
He/she is accountable for the scientific consistency and robustness of clinical and epidemiological data for the data that cannot be processed by computerized means, and ensures that the study data are complete and consistent from a medical perspective, in close collaboration with the CRDL or the Epidemiology Lead.

Key Responsibilities:

The main responsibility of the MDR is to ensure that the study data is complete and consistent from a medical perspective in close collaboration with the CRDL or the Epidemiology Lead.
He/she is responsible for the scientific consistency and robustness of clinical and epidemiological data that cannot be processed by computerized means:
- responsible for the adequacy between protocol and CRF;
- responsible for the specification and review of subject information;
- close collaboration with the study CRDL whenever medical input is required;
- responsible for manual review of the data in close collaboration with the Clinical Data Reviewers and the Clinical Research and Development Lead (CRDL) or Epidemiology Lead.
The job encompasses, but is not be limited to, the following tasks.
- During study set-up phase, the MDR specifies the data review checks (s)he will perform on the study data, in the data review plan of the study. These checks are manual checks that cannot be automated and which need a holistic subject approach and a deep understanding of the study protocol. These checks encompass subject eligibility, protocol adherence, safety and efficacy checks as appropriate.
- During the data collection phase, the MDR executes the part of the data review plan (s)he is responsible of according to the data review plan defined during the set-up phase. (S)He works with SDM/PDM to amend the data review plan as necessary during the study. (S)He sends, follow-up and closes the data queries generated from their data review. The MDR performs his/her data management activities in accordance with the SOPs, procedures and other guidelines ruling them.

Our Offer:

At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.

The department:

Patient-focused Research and Development (R&D) is the heart of our business. Our R&D department seeks to discover and develop new vaccines, to protect against diseases where vaccines are not yet available and to improve on those vaccines that already exist. Part of our R&D programme targets diseases particularly prevalent in the developing world, including the World Health Organisation's three priority diseases - HIV/AIDS, tuberculosis and malaria. Research into candidate vaccines for other diseases of the developing world, such as dengue are at an earlier stage of development.
When it comes to developing the vaccines of the future, we're looking for real experts in their respective fields who are interested in working in the stimulating environment of an international healthcare company.
We emphasise the value of teamwork and we look for people ready to share our values of transparency, respect, integrity and patient focus.

Our Company:

GSK is one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

GSK Vaccines is one of the world's leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world's countries.
For further information, please visit www.gsk.com.

Contact information:
You may apply for this position online by selecting the Apply now button.

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jobDetails

Desired profile

Basic qualifications:
• Master degree, PhD or equivalent acquired experience in Life sciences or Medical
• One year of experience in a disease area (academic or professional)
• Professional experience in Data Management including the set-up of databases will be an asset

Preferred qualifications:
• Organized
• Detail oriented
• Business understanding
• Written English