The Recruitment Co are recruiting an experienced Clinical Trials Software Support Engineer to join our clients team. A world-leading manufacturer of high-quality technical products.

Contract: Permanent
Salary: Up to £35,000p.a
Shifts: Full time Days

The Role:
Our client undertakes numerous clinical trials in-house and has developed bespoke software to facilitate this function. This software is used to manage each individual appointment, provide step-by-step guidance on the procedures to be followed along with real-time data collection at each step. The successful candidate will be responsible for maintaining and improving the existing system, providing day-to-day support and ensuring optimal performance and data integrity across numerous clinical suites.

The company has also developed complex image analysis tools that allow quantification of key metrics such as hair counts pre and post treatment. These automated tools are utilised to determine the efficacy of the Companies products using high resolution images captured during the clinical studies. You will be responsible for maintaining, supporting and improving the existing system with a particular focus on ensuring accuracy and integrity of the data.

In addition to direct support of the clinical department, you will be involved in the development of document management systems for the entire business. As the company operates according to numerous International Regulatory Standards, i.e., EU Medical Device Directive and the USA FDA, accurate document control is vital to the ongoing function of the business.
The successful candidate will be heavily involved in the development of a business-wide document management system.

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 analytics 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.

• Proactively support the development of a business-wide document management system that captures inputs from design/development/clinical/regulatory and manufacturing departments.

Key Objectives/KPI’s:

• 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, Analytics Software and Analysis Software
• Develop remote access capability for future decentralized clinical trials to improve patient experience

Essential Experience:

• 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
• Powershell script development for file management/cloud storage (Sharepoint/Azure)
• Collection of web-based customer data using standard analytics packages
• Maintaining a high level of documentation and validation reports on the tools developed
• Familiarity with Data Protection Rules and Regulations
• App Development

Ideal Experience:

• Managing EDC solution for clinical trials
• Data analysis experience
• Security management and encryption experience
• Hardware and software interface experience

If you have the required skills and experience required for this role then please submit your CV for immediate response.
CPSwansea

The Recruitment Co. is an equal opportunities employer and we’re committed to diversity and inclusion in the workplace.