IRT Project Manager, Remote US

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

Job Overview

The IRT Project Manager is accountable for the client's study specific Interactive Response Technology (IRT) implementation, ongoing conduct support, closeout and decommission. Provides subject matter expertise, leads study specific implementation, ensures on time delivery, and remediation of support issues.

Summary of Responsibilities

• Lead study-specific IRT Implementation Teams, coordinating cross-functional stakeholders including Clinical Trial Supply, Global Clinical Operations, Biostatistics, Data Management, and vendors.
• Create and manage IRT-related timelines and deliverables.
• Conduct internal review meetings for vendor-written specifications and integration documents.
• Plan, facilitate, and lead IRT study review meetings.
• Ensure completion and approval of all IRT documentation, including specifications.
• Serve as the primary point of contact for the IRT vendor for study-specific matters.
• Ensure compliance with relevant regulations such as GxPs and ICH E6.
• Provide guidance to the IRT Implementation Team on optimal system utilization.
• Act as a subject matter expert on IRT best practices and share lessons learned across teams.
• Define and complete initial documentation for scope of work requests from vendors.
• Review and provide expert input on User Requirement Specifications and other IRT-related documents.
• Review and approve UAT schedules aligned with URS.
• Create study-specific IRT Test Plans and test scripts.
• Facilitate UAT execution, coordinate issue resolution with vendors, and ensure proper documentation.
• Define and oversee data exchange requirements between IRT and other systems.
• Collaborate with stakeholders to determine integration solutions.
• Manage initial and ongoing testing to ensure efficient and error-free data transfers.
• Guide study teams on site-initiated data changes and vendor implementation.
• Facilitate collection of closeout deliverables from IRT vendors.
• Maintain a study-specific issue and risk log, documenting root causes, corrective actions, and preventive measures.
• Advise on system changes post-launch to ensure alignment with study and program needs.
• Manage study-specific IRT contracts, budgets, and change orders.
• Support the Global IRT Lead in process governance and standardization.
• Maintain consistency in IRT terminology, functionality, and reporting across studies.
• Assist in metrics collection and reporting.
• Recommend improvements to quality procedures and best practices.
• Conduct or develop IRT-related training for internal teams.
• Foster collaboration across internal stakeholders including Clinical Trial Supplies, eClinical Technology, Global Clinical Operations, Biostatistics, Data Management, Clinical Quality, Regulatory, and Outsourcing.
• Provide regular updates to the Line Manager and elevate issues as needed.
• Perform all other duties as needed or assigned.

Qualifications (Minimum Required)

• University / college degree (life sciences, health sciences, information technology or related subjects preferred) or a certification in allied health professions from an appropriate accredited institution.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Fluent in English, both written and verbal.

Experience (Minimum Required)

• 5-6 years of relevant experience in clinical systems project management, with a strong focus on or IRT and/or eCOA platforms
• Hands-on experience in User Acceptance Testing (UAT), including planning, execution, defect tracking, and system go-live support.
• Proven ability to manage outsourced technology vendors and collaborate with sponsors and cross-functional teams.
• Strong problem-solving skills with a proactive and detail-oriented approach to issue resolution and system validation.
• Effective oral and written communication skills for stakeholder engagement, documentation, and reporting.
• Solid understanding of the clinical trial lifecycle, including system implementation, data flow, regulatory compliance, and TMF documentation.
• Ability to work independently and collaboratively in a fast-paced, team-oriented environment with minimal supervision.
• Strong time management and prioritization skills, with the ability to meet tight deadlines while maintaining high-quality standards.
• Demonstrated self-motivation, accountability, and ownership of assigned tasks.
• A cooperative and team-oriented mindset, with a willingness to support peers and contribute to shared goals.

Pay Range

$110,000-$125,000

Benefits

All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including:

• Medical
• Dental
• Vision
• Life
• STD/LTD
• 401(K)
• Paid time off (PTO) or Flexible time off (FTO)
• Company bonus where applicable

Location

#LI Remote # LI CS1

Application Deadline

11/10/2026

Learn more about our EEO & Accommodations request here.