Technical System Owner
- Master in Engineering, Life Sciences, Computer Sciences or equivalent.
- 5 years experience in Clinical Research, Information Systems experience and demonstrated matrix leadership skills.
- Knowledge of IT validation methodology is required.
- Strong Project Management skills.
- Experience of Clinical Data Management and supporting information management systems.
- Knowledge of ICH, GCPs, etc.
Language: English and French are a MUST. Other languages are a plus (Italian/ German/ ....)
- Good writing skills.
- Ability to work in a global organization and a complex matrix structure.
Please see "Basic Qualifications".
- The Senior Technical System Owner is accountable for the technical implementation and support of one or more Information Systems, in collaboration with their Business Owner and acts as a Subject Matter Expert.
- This role ensures the Information Systems she/he is responsible for are at the top of industry standards with respect to quality, performance and timelines.
- Accountable for the technical validation of Information Systems in line with GCP, 21 CFR part 11 and other applicable regulations in collaboration with IT Risk & Compliance and Quality & Risk Management.
- Collect and formalize the business requirements provided by the Business Owner and translate them into technical requirements.
- Supervision of third party providing, hosting and/or maintaining Information Systems.
- Qualifying the installation and operational functionalities of the Information System against the business requirements.
- Development and maintenance of interfaces/integration between Information Systems and their environment.
- Development of the technical documentation supporting Information Systems end-users (eg. Userguide).
- Maintain Information System through compliant change requests throughout their lifecycle up to decommissioning.
- Ensure availability of the Clinical System(s) for productive use by defining and setting up a support model and ensuring the second or third line technical support.
- May act as Subject Matter Experts in supporting Business Excellence in the implementation of new processes, trainings, systems, vendor quality assessments, audits and inspections.
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.
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.
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.
You may apply for this position online by selecting the Apply now button.
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