Operations Software Engineer - Operations

About Signant Health

At Signant Health, we help bring life-changing treatments to patients faster. We are a global evidence generation company that supports clinical trials with smart technology, scientific expertise, and hands-on operational support — so better data leads to better decisions in healthcare. We embrace AI and advanced technologies to enhance every aspect of what we do, from data analysis to operational efficiency.

Our teams work at the intersection of science, technology, and patient experience, delivering digital solutions powered by AI innovation that make clinical trials more efficient, more accurate, and more accessible around the world. Trusted by leading pharmaceutical companies and CROs, our platforms and services support studies across more than 90 countries and have contributed to hundreds of new drug approvals. 

If you are motivated by meaningful work, global impact, and innovation in clinical research and digital health — including the opportunity to work with cutting-edge AI technologies — you will find purpose and opportunity at Signant Health.

About the Role

The Operations Software Engineer creates, enhances, and maintains business applications, configures custom code to support the company’s business needs, and moves those configurations through a standard SDLC progression. The Engineer is accountable for project deliverables in line with quality targets and SLAs, while adhering to best practices, Good Clinical Practice (GCP), company processes, and global industry regulations. The ideal candidate has basic product knowledge and basic knowledge of user applications.

KEY ACCOUNTABILITIES – Function

Application Development / Study Configuration

• Work with Global Project Management and the Solutions team to understand business requirements for assigned tasks
• Develop and maintain application components and study configurations, following all coding standards
• Create robust, well-documented code; design, create, and modify database objects as required
• Complete unit testing, create documentation, and perform peer reviews as required
• Support all phases of verification and testing by efficiently diagnosing and resolving defects
• Adhere to source control, versioning best practices, and operational process requirements when executing study configuration tasks
• Collaborate with the Delivery Manager/Lead to keep projects on time
• Coordinate with the Software Engineering team on design patterns, standards, customizations, and resource capacity planning
• Communicate status updates on assigned tasks to internal and external stakeholders, and request requirements or design clarifications when necessary
• Support Global Technical Delivery in meeting its business objectives, and adopt and support iterative process improvements
• Job performance is measured individually, as it pertains to team goals aligned with corporate objectives for Global Technical Delivery and the values of Signant Health

Site Support Responsibilities (Rater Station only)

• Adhere to source control, versioning best practices, and operational process requirements
• Perform general site support in support of study configurations in the field, as required
• Diagnose and resolve defects as part of general site support
• Prepare and confirm all required change control documentation, including updates to design and other technical documents
• Deploy resolutions to testing and production environments as required

Quality System Responsibilities

• Perform all work in accordance with documented Standard Operating Procedures (SOPs) and Working Instructions, and adhere to Good Clinical Practice (GCP), 21 CFR Part 11, and other regulatory requirements as required

KNOWLEDGE, SKILLS & ATTRIBUTES

Essential:

• 2–3 years of experience professionally developing software
• Detailed knowledge of software development processes and practices
• Programming experience in any language
• Knowledge of application development, configuration, and support areas
• Ability to work independently and resourcefully toward quality, high-performance solutions
• Problem-solving skills and good decision-making, with the judgment to escalate when necessary
• Ability to provide concise, accurate feedback to clients and teams on progress and outcomes
• Ability to work in a team environment, providing backup support to team members
• Ability to establish and maintain effective work relationships within and across functional areas
• Strong analytical skills, with the ability to comprehend business requirements

Specific to IRT and Rater Station products:

• Microsoft SQL Server Management Studio, SQL Server Reporting Services, and T-SQL
• Microsoft Visual Studio IDE, ASP.NET MVC, and C# with LINQ
• Web code and data standards: HTML, JavaScript, XML, JSON, and REST

Desirable:

• Agile Scrum methodologies
• Atlassian Suite tools such as Bitbucket, Confluence, Jira, Xray, and Jira Service Management
• Source control software such as Team Foundation Server, Bitbucket, or other Git-based tools
• Microsoft SQL Server Integration Services (SSIS) and Reporting Services (SSRS)
• Microsoft Azure, Cosmos DB, and Kubernetes
• REST APIs
• Experience leading software design and development efforts on assigned projects
• Experience estimating project time for quoting development and support tasks
• Willingness to share knowledge openly with others, including lessons learned
• Willingness to work flexible hours
• Familiarity with GCP and 21 CFR Part 11

• Familiarity with defect tracking software