Clinical Data Scientist
Posted on Dec 9, 2018 by GlaxoSmithKline
The purpose of this role is to deliver the data management components of a series of clinical studies or project from data capture from multiple sources, through improving in-stream data flow and data quality and data integration.
• Leads deliverables for at least two global studies or multiple early phase studies and/or at least one project at any point in time.
• Champions the development and use of therapy area standards.
• Lead role with third party suppliers, assessing capability, managing delivery and performance.
• Global study level contribution as Data Quality Lead (DQL) or in close collaboration with DQL and other members of the study team.
• Point of contact for more complex data management and data quality considerations including regular contact with monitors.
• Provides input to protocol and other plans e.g. Monitoring Plan, Protocol Deviation Management Plan, Reporting & Analysis Plan and Study Data Quality Plan during the planning phase.
• Manages in-stream data flow activities and delivers a quality database in accordance with the Study Data Quality Plan.
• Inputs into the data capture tools for a clinical study, including the eCRF and eCOA.
• Develops and manages the execution of the validation and integration plans, including dataset definitions and external data sources. Manages vendor performance against study-specific Service Level Agreements.
• Responsible for the set-up and maintenance of TMF section 10 and DM TMF artefacts throughout the study life cycle.
• Trains monitors and site staff on use of data collection tools and query management process.
• Subject Matter Expert for the Data Management Community in a specified area(s) of functional expertise.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.
If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact . This will help us to understand any modifications we may need to make to support you throughout our selection process.
Application closing date: 7th December 2018
Thank you for your interest in this opportunity.
Why You?Basic qualifications:
• Bachelor's degree, and early phase clinical trial experience.
• End-to-end global medicine development experience.
• Pharma, CRO and/or ARO experience.
• Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP).
• Understanding of the tools of the trade, such as standards.
• Understanding of disease area.
• Understanding of laboratory data.
• Post Graduate Degree in Scientific Discipline.
• SDTM Conversion knowledge.
• Experience working with InForm 6.0, DataLabs or Rave.
We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. We aim to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our scientific and technical know-how and talented people. We strive to attract the best people and to create an environment that empowers and inspires.
You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1- (US Toll Free) or +1 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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