Solution Engineer - Operations

Solution Engineer - US Remote

Role Purpose

The Solution Engineer is responsible for collaborating with Sponsors/Customers, Clinical, Global Project Management (GPM), Data Management, and the matrixed Global Technical Delivery (GTD) team to design tailored solutions for clinical trials using Signant Health’s product portfolio. They analyze study protocol requirements and define solutions, leveraging scientific guidance, electronic clinical outcome assessment (eCOA) best practices, and Signant’s standards. This role ensures that the proposed solutions align with study needs, are feasible to implement, and adhere to quoted timelines and budgets. Additionally, the Solution Engineer translates business needs into system requirements and may contribute to developing and documenting processes and procedures.

Key Accountabilities

• Collaborate with Solution Engineers and other stakeholders to ensure that clinical trial protocols and design requirements are clearly understood, actionable, and feasible for implementation. Analyze protocols and scopes for simple to moderately complex projects.
• Develop functional requirements documentation based on design inputs from Senior or Lead Solution Engineers, as necessary.
• Utilize tools and methodologies such as interviews, document analysis, use cases, and workflow analysis to gather and clarify requirements.
• Update and manage requirements and specifications throughout the software development lifecycle (SDLC). Ensure all validation processes are followed and produce validated documents for questionnaires.
• Reconcile conflicting information, identify and assess potential risks, and translate abstract requirements into actionable system specifications.
• Ensure adherence to best practices and standards in every project implementation.
• Coordinate with Localization teams to develop translated versions of master questionnaires (specific to Rater Station projects).
• Configure applications and support SDLC and validation documentation review and approval processes as needed (specific to Rater Station projects).
• Create data extract requirements and associated deliverables for Rater Station projects, including posting data extracts and developing custom report requirements.
  
  

Decision Making and Influence

• Own the design elements of questionnaires and system requirements.
• Identify and communicate project risks effectively.
• Establish and promote best practices for questionnaire creation, system requirements, integration specifications, and overall project design.
• Influence the end-user experience and ensure data integrity.
• Interface effectively with internal and external teams, including sponsors.
  
  

Knowledge, Skills & Attributes

Essential:

• Bachelor’s degree or equivalent professional experience.
• 2-3 years of experience as a Business Analyst or in a similar role.
• Strong knowledge of Software Development Life Cycle (SDLC) implementation.
• Proven ability to gather, analyze, and document information from diverse sources into technical and non-technical documentation.
• Excellent analytical and problem-solving skills with a proactive approach to addressing challenges.
• Strong conflict resolution skills, balancing competing goals and interests effectively.
• Commitment to personal development in technical, clinical, and interpersonal skills.
• Exceptional communication skills, including writing, documentation, and presentation. Builds effective relationships with team members.
• Positive team player and self-starter, able to work with moderate guidance and direction.
• Proficiency in Microsoft Office applications, including Word, Excel, Visio, and PowerPoint.
  
  

Desirable:

• Background or experience in software development.
• Experience with user experience/interface design.
• Familiarity with GCP and 21 CFR Part 11 regulations.
• Experience with SQL queries.
  
  

– REMOTE

At Signant Health, accepting difference isn’t enough—we celebrate it, we support it, and we nurture it for the benefit of our team members, our clients and our community. Signant Health is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status.

Apply Now