Clinical Trials Software Engineer

Jennifer Griffiths Recruitment are looking for a Clinical Trials Software Engineer for a Client in the Swansea area.

Overall Job purpose

Support ongoing clinical trials to prove the safety and efficiency of products developed by the company.  Development of document management system for the business.

Key Responsibilities

* Maintain and improve the existing Clinical Trial Software and Hardware system, providing day to day support, and ensuring optimal performance and data integrity across numerous clinical suites.

* Further develop our in house EDC solution allowing integration of various APIs.

* Maintain, support, and improve the existing Image Analysis Software with a particular focus on ensuring accuracy and integrity of the data.

* Maintain and improve, through integration, our separate analytic software package ensuring no commercial restrictions.

* Generate one unified clinical system allowing users to move seamlessly between applications and features from set-up to data delivery.

* Build in key features to enhance performance, EDC, EPRO, ECOA, EConsent, API.

* Safeguard data with robust backup systems, advanced data encryption and audit trails.

* Provide support and infrastructure ensuring maximum performance.

* Ensure documentation is inspection ready.  Documentation must meet inspection requirements and must be updated with each release.

* Pro actively support the development of a business wide document management system that captures inputs from design/development/clinical/regulatory and manufacturing departments.

Key Objectives

* Streamline clinical trials making user activities/tasks easier and faster.

* Integrate our EDC Solution with EPRO/ECOA and Econsent.

* Design solutions for study set-up, managing multiple sites and user roles.

* Design solutions for ISO information security management certification and FDA 21CRF compliance.

* Author software validation documents.

* Author Standard Operating Procedures including trouble shooting for the clinical team; correct use of Clinical Trial Management Suite Software, Analytic Software and Analysis Software.

* Develop remote access capability for future decentralized clinical trials to improve patient experience.

Skills and experience

Essential

* Windows forms applications in VB/C#/NET including: GUI Design, Real time data collection, manipulation, and storage (SQL database).  Automatic report generation of collated data, primarily direct export to MS Excel.  Image capture and post-processing.

* SQL database design, development, implementation and query construction using industry standard tools (SQL Server, Microsoft SQL Server Management).

* Device interfacing via Serial COM, Bluetooth, Wi-Fi etc.

* Power Shell script development for file management/cloud storage (Sharepoint/Azure).

* Collection of web-based customer data using standard analytic packages.

* Maintaining a high level of documentation and validation reports on the tools developed.

* Familiarity with General Data Protection Rules and Regulations.

* App development.

Essential

* Managing EDC solution for clinical trials.

* Data analysis experience.

* Security management and encryption experience.

* Hardware and software interface experience.

The salary is £30 – £35k per annum.