Remote IRT System Designer – Clinical Trials Lead

Spectraforce; Illinois; Remote; USD 48,000 - 55,000; Full time

Job summary

Spectraforce is seeking an IRT System Designer or IRT Lead to join the Data Science group for a 1-year assignment. The role supports IRT activities across study teams with potential for fully remote work depending on location.

Immediate ramp-up and minimal training are expected to deliver on critical IRT tasks. The ideal candidate has a Bachelor’s degree and 3+ years in IRT or 2 years if coming from an IRT vendor, with experience in IRT specification writing, EDC/EDC integrations knowledge, and

Qualifications

• Bachelor’s degree and 3+ years IRT experience (exception possible with 2 years from an IRT vendor).
• Clinical research experience with knowledge of ICH/GCP practices.
• Experience drafting IRT specifications and requirements documentation.
• Experience managing IRT project lifecycles from build to study closure.
• PMP is a nice-to-have; general knowledge of EDC and system integrations.

Responsibilities

• Develop common data standards and ensure designs meet protocol requirements.
• Establish methodology to design and deliver clinical trial systems; benchmark against industry standards.
• Ensure TA- and program-level consistency across the design team.
• Lead on-time design and delivery of new clinical systems and integrations (EDC, IRT, ePRO).
• Use project management tools to track study progress and mitigate risks.
• Coordinate with DSS and cross-functional teams to meet objectives.
• Adhere to GCP, ICH, SOPs and evolving regulations; mentor team members.
• Lead process improvements and innovation within DSS and cross-functional teams.

Skills

Biopharma/ICH-GCP

IRT specification drafting

IRT project management

IRT test scripts & UAT

Prioritization & multi-projects

Education

Bachelor’s degree

3+ years IRT experience

Tools

EDC

IRT systems

ePRO systems

Job description

Spectraforce is seeking an IRT System Designer or IRT Lead to join the Data Science group for a 1-year assignment. The role supports IRT activities across study teams with potential for fully remote work depending on location.

Immediate ramp-up and minimal training are expected to deliver on critical IRT tasks. The ideal candidate has a Bachelor’s degree and 3+ years in IRT or 2 years if coming from an IRT vendor, with experience in IRT specification writing, EDC/EDC integrations knowledge, and