Clinical Solutions Engineer – SDLC & eCOA

Signant Health; Northern (KY); On-site; USD 85,000 - 120,000; Full time

Job summary

Signant Health is seeking a Solution Engineer to design clinical trial solutions, translating study requirements into system specs. You will liaise with Sponsors, Clinical, GPM and GTD to ensure feasible, timely implementations aligned with product capabilities. Strong SDLC, documentation, and communication skills are essential.

You will analyze protocols, define requirements, and support validation and process documentation while maintaining quality and compliance across projects.

Qualifications

• Bachelor’s degree or equivalent years of professional role.
• 2-3 years’ experience functioning as Business Analyst or similar role.
• In depth experience with Software Development Life Cycle (SDLC) implementation.
• Gathering information from a wide variety of sources and crafting it into documentation.
• Excellent analytical and problem‑solving skills.
• Ability to resolve conflicts between people and competing goals.
• Desire for developing technical, clinical, and interpersonal skills.
• Strong written communication and presentation abilities; builds relationships.
• Self-starter, good team player with moderate guidance.

Responsibilities

• Collaborate with Solution Engineers and others to understand and implement questionnaire and protocol design.
• Produce functional requirements documentation based on design inputs.
• Use interviews, document analysis, use cases, and workflow analysis to gather requirements.
• Update requirements throughout the software development lifecycle with validated documents.
• Assess risks and reconcile information to translate requirements into actionable implementation.
• Ensure best practices and standards are followed in implementations.
• Coordinate with Localization for translated master questionnaires.
• Provide support for SDLC and validation documents; assist with reviews.

Skills

SDLC experience

Analytical problem-solving

Communication skills

Team collaboration

Documentation writing

Education

Bachelor’s degree or equivalent years of professional role

Tools

Microsoft Word

Microsoft Excel

Visio

PowerPoint

Job description

Signant Health is seeking a Solution Engineer to design clinical trial solutions, translating study requirements into system specs. You will liaise with Sponsors, Clinical, GPM and GTD to ensure feasible, timely implementations aligned with product capabilities. Strong SDLC, documentation, and communication skills are essential.

You will analyze protocols, define requirements, and support validation and process documentation while maintaining quality and compliance across projects.