Clinical Systems Administrator
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
Following the deployment of a Global Clinical System, a new career opportunity has arisen for a Clinical Systems Administrator to support the management, development and implementation of system modules not currently in use at Quotient.
The Clinical Systems Administrator will lead the day-to-day management of assigned Clinical Systems as well as leading the project implementation for future upgrades and support other clinical systems as assigned within Nottingham, Miami and/or Edinburgh Quotient offices.
You will ensure the software and applications comply & adhere to regulatory expectations, such as EudraLex Volume 4, Annex 11, 21 CFR Part 11 and Good Clinical Practice (GCP) standards and provide support to Global Clinical Operations including collation/reporting function KPIs.
Main tasks and responsibilities include:
•Act as Systems Administrator for all assigned systems, software and applications
•Manage the deployment, set-up, configuration, validation (IQ/OQ/PQ, validation plans, user requirements, software requirements, risk assessments, using GAMP requirements), improvements and upgrade implementation, maintenance; develop custom reports and execution of test scripts for the software and applications
•Primary external contact for assigned systems vendors for day-to-day oversight/management, regular vendor meetings, Governance meetings and system upgrade activities
•Primary internal contact for assigned systems including liaising with representatives across operational functions, QA and IT for day-to-day, troubleshooting, regular user meetings and system upgrade activities
•Lead the global internal multi-functional taskforce/SMEs assigned to monitor system use, measure quality, issues, potential improvements, system upgrades/validation etc.
•Partner with the functional area staff and IT Services for troubleshooting including leading and coordinating technical issue investigations and manage technology resolution implementations
•Independently plan, manage, and execute assignments, contribute to project planning meetings, communicate any changes in plans or timelines
•Develop and maintain Standard Operating Procedures (SOPs), protocols, change controls, action plans, and other technical documents for software and applications
The successful candidate will have a bachelor’s degree or higher in a Life Science or IT subject and have at least 2 years’ experience working in clinical research/manufacturing, GCP, GLP, or IT environment.
Other skills and experience required:
- Experience of working on projects and with multi-functional project teams
- Experience in communicating and influencing multiple stakeholders
- Thorough knowledge of GCP regulations with special attention to data integrity and system validation
- Able to communicate clearly and write in a proficient manner within a regulatory environment including change controls, quality investigations, reports, and SOPs
- Able to work independently and as part of a multi-site team with internal and external vendor teams
- Competent in the use of Microsoft Office packages including Word, Excel, PowerPoint, and MS Project etc.
- Awareness of computer system development and related concepts
In return, you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.