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.

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

KEY ACCOUNTABILITIES

Application Development / Study Configuration

Operations Software Engineer (UP - GTD) – Works with Global Project Management and the Solution team to understand business requirements for assigned tasks

Develops and maintains application components (under supervision).

Support Global Technical Delivery in meeting business objectives outlined in Goals and Objectives.

Operations Software Engineer (GTD) Works with the Solution team to understand the business requirements for assigned tasks.

Supports all phases of verification/testing by efficiently diagnosing and resolving defects.

Collaborates with the Delivery Manager/Lead to keep the project on time.

Coordinates with the Software Engineer team to understand design patterns, standards, customizations, and resource capacity planning.

Understands and follows all coding standards.

Creates robust, well-documented code.

Designs, creates, and modifies database objects as required.

Completes unit testing, creates documentation, and executes peer reviews as required.

Adheres to source control, versioning best practices, and operational process requirements when executing study configuration tasks.

Regularly communicate status updates of assigned tasks to internal and external stakeholders.

Requests requirements and design clarifications when necessary.

Willingly and openly adopts and supports iterative process improvements.

Job performance 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)

Adheres to source control, versioning best practices, and operational process requirements.

Perform general Site Support in support of the study configurations in the field, as required.

They are diagnosing and resolving defects as part of general site support.

Prepare/confirm all required change control documentation, including updates to design and other technical documents.

Deploys resolution to testing and production environment as required.

Quality System Responsibilities

Performs all work following documented Standard Operating Procedures (SOPs), Working Instructions, Adheres to Good Clinical Practices (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 process and practices.

Programming experience in any language.

Knowledgeable about application development, configuration, and support areas.

Ability to work independently and resourcefully toward quality and high-performance solutions.

Problem-solving skills and good decision making to escalate when necessary.

Ability to provide concise and accurate feedback to the client and the teams about progress and outcomes.

Ability to work in a team environment providing backup support to team members.

Ability to establish and maintain effective work relationships with co-workers within and across functional areas.

Strong analytical skills with an ability to comprehend business requirements.

Specific to Products of IRT and Rater Station

Microsoft SQL Server Management Studio and Server Reporting Services and T-SQL

Microsoft Visual Studio IDE ASP.NET MVC, C# w/LINQ

Web code and data standards for HTML, JavaScript, XML, JSON, REST

Desirable:

Agile Scrum methodologies.

Atlassian Suite tools, such as Bit Bucket/Confluence/JIRA/X-ray/Jira Service Manager.

Source Control Software, such as Team Foundation Server, Bit Bucket, or other Git-based source control.

Microsoft SQL Server Integration Services.

Microsoft SQL Server Reporting Services.

Microsoft Azure, Cosmos DB, Kubernetes.

REST APIs.

Leading software design and development efforts on assigned projects.

Experience estimating project time needed for quoting development and support tasks.

Experience, capability, and 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.

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