Exciting Job Opportunity for a Talented Software Engineer!

Join an innovative team at the forefront of cutting-edge technology, contributing to groundbreaking clinical trials without revealing the company name. We are seeking a dynamic and multi-skilled Software Support Engineer to play a pivotal role in revolutionizing the development and enhancement of our unique software systems.

About : They're a trailblazing company dedicated to proving the safety and efficacy of our revolutionary products through extensive in-house clinical trials. Our bespoke software, designed to manage every facet of the trial process, needs your expertise to maintain, improve, and elevate its performance. Your mission, should you choose to accept it, involves supporting the ongoing clinical trials, ensuring data integrity, and optimizing the software's capabilities across various clinical suites.

Your Impact: As a Software Engineer, you'll be the driving force behind our existing Clinical Trial Software and Hardware system, ensuring it operates seamlessly. Your responsibilities extend to enhancing our in-house EDC solution, maintaining and improving our Image Analysis Software, and integrating analytics software without any commercial restrictions.

Key Responsibilities:

• Elevate our Clinical Trial Software and Hardware system, providing daily support and ensuring optimal performance across multiple clinical suites.
• Develop our in-house EDC solution to integrate various APIs seamlessly.
• Enhance the existing Image Analysis Software, focusing on data accuracy and integrity.
• Integrate our separate analytics software, ensuring unrestricted functionality.
• Build a unified clinical system for a seamless user experience, incorporating key features like EDC, ePRO, eCOA, eConsent, and API.
• Strengthen data security with robust backup systems, advanced encryption, and audit trails.
• Support the creation of a business-wide document management system in compliance with international regulatory standards.

Key Objectives:

• Streamline clinical trials for easier and faster user activities.
• Integrate EDC solution with ePRO/eCOA and eConsent.
• Design solutions for study set-up, managing multiple sites, and user roles.
• Achieve ISO information security management certification and FDA 21CRF compliance.
• Author software validation documents and Standard Operating Procedures.
• Develop remote access capability for future decentralized clinical trials.

Skills, Know-How & Experience: Must-Have:

• Proficiency in Windows forms applications in VB/C#/.NET, including GUI design.
• Real-time data collection, manipulation, and storage (SQL database).
• Automatic report generation with direct export to MS Excel.
• Image capture and post-processing skills.
• SQL database design, development, and implementation using industry-standard tools.
• Device interfacing via Serial COM, Bluetooth, Wi-Fi, etc.
• Powershell script development for file management/cloud storage.
• Web-based customer data collection using standard analytics packages.
• Thorough documentation skills and familiarity with Data Protection Rules and Regulations.
• App development experience.