Remote IRT Project Manager

Fortrea; Oregon; Hybrid; USD 110,000 - 125,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

PTO

Job summary

Fortrea is seeking an IRT Project Manager to lead study-specific IRT implementation, oversee timelines and vendor collaborations, and ensure on-time delivery across the lifecycle. You will facilitate cross-functional meetings, review technical specifications, and ensure regulatory alignment with GxP and ICH E6 for successful study execution.

You will manage testing, data exchanges between systems, and post-launch optimizations while mentoring team members and sharing best practices for IRT

Qualifications

• 5-6 years of clinical systems project management experience with focus on IRT and/or eCOA platforms.
• Hands-on UAT planning, execution, defect tracking and go-live support.
• Proven ability to manage outsourced technology vendors and collaborate with sponsors.
• Strong problem-solving, proactive and detail-oriented issue resolution skills.
• Excellent written and oral communication for stakeholder engagement and reporting.
• Solid understanding of the clinical trial lifecycle, system implementation and TMF documentation.
• Ability to work independently in a fast-paced, team-oriented environment.
• Strong time management and prioritization to meet tight deadlines while upholding quality.
• Self-motivated with accountability and ownership of tasks.
• Cooperative mindset to support peers and achieve shared goals.

Responsibilities

• Lead study-specific IRT implementation teams and coordinate cross-functional stakeholders.
• Create and manage IRT timelines and deliverables.
• Review vendor specifications and integration documents.
• Facilitate study review meetings for URS, URS-based deliverables and UAT.
• Ensure completion and approval of IRT documentation.
• Serve as primary contact for the IRT vendor on study matters.
• Ensure compliance with GxP, ICH E6 and related regulations.
• Provide guidance on optimal system utilization and best practices.
• Share lessons learned on IRT across teams and define scope-of-work docs.
• Review and input on URS and other IRT documents; approve UAT schedules.
• Create study-specific IRT Test Plans and test scripts; oversee UAT execution.
• Coordinate data exchange requirements between IRT and other systems.

Skills

IRT management

UAT planning

Vendor management

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in life sciences/IT or related field

Job description

Fortrea is seeking an IRT Project Manager to lead study-specific IRT implementation, oversee timelines and vendor collaborations, and ensure on-time delivery across the lifecycle. You will facilitate cross-functional meetings, review technical specifications, and ensure regulatory alignment with GxP and ICH E6 for successful study execution.

You will manage testing, data exchanges between systems, and post-launch optimizations while mentoring team members and sharing best practices for IRT