Data Specialist

Salary: Professional Services, Level 3a, £37,977 - £42,360 plus benefits

Location: Stadium House, White City campus (hybrid)

Job Summary

We are looking for a new Data Specialist to help support the Clinical Data Systems (CDS) Team at the Imperial Clinical Trials Unit (ICTU) to deliver high quality, thoroughly tested and documented eCRFs (electronic case report forms) using EDC systems (e.g., OpenClinica v4.0) for healthcare related studies through design, development, authorship and execution of test scripts, and support to studies. The remit of the CDS team is to provide development and support of an Electronic Data Capture (EDC) system for studies undertaken in ICTU and researchers College-wide. 

Based within the School of Public Health at Imperial College London, ICTU works to bring together academic and trial management expertise. Trial designs range from early stage to large confirmatory studies, with a focus currently on a number of therapeutic areas including cancer, cardiovascular and metabolic diseases, respiratory disease, emergency medicine and critical care, HIV and infectious diseases. Other key areas currently being developed include surgery and hepatology research.

Duties and responsibilities

You will be:

• Responsible for production support tasks by providing high quality user management and ongoing support of EDC systems for healthcare related studies to ensure high availability and excellent user support to study teams. 
• A main point of contact for production related requests and issues, competently managing the service desk ticketing system in the Production Support team, fully tracking any requests and incidents raised by study teams in relation to the supported EDCs until fully completed/resolved. 
• Developing and testing solutions that are fit for purpose and compliant with regulatory requirements, undertaking a variety of activities within the development and testing of eCRFs including author, design, develop eCRFs and edit checks based on user requirement specifications, following standards and methodologies, across a variety of different studies, phases and therapeutic areas.

Essential requirements include:

• Previous experience with EDC systems
• Background in clinical Data Management or eCRF design/development
• A degree or equivalent in computer science or a relevant subject and/or relevant experience
• An understanding of the key stages and processes involved in the implementation of eCRFs, together with use of formal development life cycle methodologies.
• Experience of working in a clinical trials unit, the Pharmaceutical industry or for a Contract Research Organisation
• Previous experience of programming languages/database design
• Experience of working to, authoring and reviewing Standard Operating Procedures, Working Instructions and User Guides
• Experience of being involved in Quality System audits / regulatory inspections.

A full list of essential and Desirable criteria can be found in the Job Description & Person Specification.

Further Information

This post is full-time and open-ended and is available immediately. You will be based at Stadium House, Wood Lane which is close to Wood Lane and White City tube stations.

For an informal discussion about the post please contact Nayan Das, Data Systems Manager, Imperial Clinical Trials Unit, n.das@imperial.ac.uk

The College is currently trialling a Work Location Framework until early 2023.  Hybrid working may be considered for this role and the role holder may be expected to work 60% or more of their time onsite, with 40% the minimum time spent onsite. The opportunity for hybrid working will be discussed at interview

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