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Country: United Kingdom
Specific Location: London
Job Title: ICTU Clinical Trials eCRF Designer/ Developer
Type of Job: Temporary
Date posted: 19 July 2019
Closing date: 1 September 2019
Imperial Clinical Trials Unit (ICTU) has a vacancy for a Clinical Trials eCRF Designer/ Developer within the InForm team reporting to the Development Team Leader. The InForm team develops and supports electronic data capture (EDC) system for clinical trials and comprises three teams with expertise in different areas so collaborative working across the team is essential
Duties and responsibilities
You will be responsible for delivering high quality eCRFs for healthcare related trials through the lifecycle of design, development and unit testing. You will also be responsible for ensuring that the solutions delivered are both fit for purpose and compliant with regulatory requirements and delivered within strict timelines.
The Clinical Trials eCRF Designer/ Developer will be expected to use Oracle’s Central Designer to author, design and develop eCRF and Edit Checks for InForm™ EDC systems based on user requirement specifications, following standards and methodologies. The eCRF Designer/Developer is expected to be involved in trials at various stages of the development lifecycle.
You should hold a degree or equivalent in computer science or a relevant subject and/or relevant experience. Previous experience with EDC (Electronic Data Capture) systems is essential e.g. InForm™. A background in clinical data management of eCRF design/development is also required.
You should understand the key stages and processes involved in the implementation of eCRFs, together with use of formal development life cycle methodologies. To add to this, you should have good knowledge of GCP and other regulatory requirements for computerised systems supporting clinical trials in the UK and International markets. You should also understand ICH-GCP and other applicable regulations associated with clinical trial data handling.
Experience of working to, authoring and reviewing Standard Operating Procedures, Working Instructions and User Guides is essential as well as awareness of General Data Protection Regulations (GDPR) and how it relates and applies to Clinical Trials.
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Closing Date: September 1, 2019
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