About The Position

The Operations Software Engineer creates, enhances, and maintains business applications, configuring custom code to support company needs and moving configurations through the standard software development lifecycle. The role is accountable for project deliverables that meet quality targets and service-level agreements while following best practices, Good Clinical Practice (GCP), company processes, and applicable global industry regulations. The position requires basic product and user-application knowledge. The engineer works with Global Project Management and solution teams to understand requirements, develops and maintains application components under supervision, and supports Global Technical Delivery objectives. Depending on assignment, the role also supports verification and testing, defect diagnosis and resolution, project coordination, database changes, documentation, unit testing, and peer review. The engineer follows coding, source-control, versioning, and operational standards; communicates task status to stakeholders; and requests clarification when needed. For Rater Station site support, the role may provide field support for study configurations, diagnose and resolve defects, prepare and confirm change-control documentation, and deploy resolutions to testing and production environments. All work must follow documented procedures and applicable quality-system and regulatory requirements, including SOPs, Working Instructions, GCP, and 21 CFR Part 11.

Requirements

  • 2–3 years of professional software development experience.
  • Detailed knowledge of software development processes and practices.
  • Programming experience in any language.
  • Knowledge of application development, configuration, and support.
  • Ability to work independently and resourcefully toward quality, high-performance solutions.
  • Problem-solving and decision-making skills, including knowing when to escalate.
  • Ability to provide clients and teams with concise, accurate feedback about progress and outcomes.
  • Ability to work in a team environment and provide backup support to team members.
  • Ability to establish and maintain effective working relationships with coworkers across functional areas.
  • Strong analytical skills and ability to understand business requirements.
  • For IRT and Rater Station products: knowledge of Microsoft SQL Server Management Studio, Server Reporting Services, and T-SQL.
  • For IRT and Rater Station products: programming experience with Microsoft Visual Studio IDE, ASP.NET MVC, C#, and LINQ.
  • For IRT and Rater Station products: knowledge of web code and data standards including HTML, JavaScript, XML, JSON, and REST.

Nice To Haves

  • Agile Scrum methodology experience.
  • Experience with Atlassian Suite tools such as Bitbucket, Confluence, JIRA, X-ray, or Jira Service Manager.
  • Experience with source-control software such as Team Foundation Server, Bitbucket, or other Git-based systems.
  • Experience with Microsoft SQL Server Integration Services.
  • Experience with Microsoft SQL Server Reporting Services.
  • Experience with Microsoft Azure, Cosmos DB, or Kubernetes.
  • Experience with REST APIs.
  • Experience leading software design and development efforts on assigned projects.
  • Experience estimating project time for development and support task quotations.
  • Capability and willingness to share knowledge and lessons learned.
  • Willingness to work flexible hours.
  • Familiarity with GCP and 21 CFR Part 11.
  • Familiarity with defect-tracking software.

Responsibilities

  • Work with Global Project Management and solution teams to understand business requirements for assigned tasks.
  • Develop and maintain application components under supervision.
  • Support Global Technical Delivery in meeting business objectives.
  • Support verification and testing phases by diagnosing and resolving defects.
  • Collaborate with the Delivery Manager or Lead to help keep projects on schedule.
  • Coordinate with Software Engineer team members to understand design patterns, standards, customizations, and resource capacity planning.
  • Follow coding standards and create robust, well-documented code.
  • Design, create, and modify database objects as required.
  • Complete unit testing, create documentation, and conduct peer reviews as required.
  • Follow source-control, versioning, and operational-process requirements when executing study configuration tasks.
  • Communicate status updates on assigned tasks to internal and external stakeholders.
  • Request requirements and design clarifications when necessary.
  • Adopt and support iterative process improvements.
  • For Rater Station site support, provide general field support for study configurations and diagnose and resolve defects.
  • Prepare or confirm required change-control documentation, including updates to design and other technical documents.
  • Deploy resolutions to testing and production environments as required.
  • Perform all work in accordance with documented SOPs, Working Instructions, GCP, 21 CFR Part 11, and other applicable regulatory requirements.
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