Remote IRT Implementation Lead

FTINC Fortrea Inc.; North Carolina; Remote; USD 110,000 - 125,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life

STD/LTD

401K

PTO/FTO

Company bonus

Job summary

Fortrea is seeking an IRT Project Manager to lead study-specific IRT implementation, ensure on-time delivery, and coordinate cross-functional teams across Clinical Trial Support, Global Operations, Biostatistics, and vendors. You will drive UAT, testing, and data integration efforts to support successful study conduct and closeout.

The role requires 5–6 years in clinical systems PM with IRT/eCOA experience, strong problem-solving, and excellent communication to align stakeholders and regulatory

Qualifications

• 5–6 years of relevant experience in clinical systems project management with focus on 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.

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.

Skills

English fluency

Vendor management

UAT planning

Education

University degree in life sciences/health sciences/IT

Certification in allied health professions

Job description

Fortrea is seeking an IRT Project Manager to lead study-specific IRT implementation, ensure on-time delivery, and coordinate cross-functional teams across Clinical Trial Support, Global Operations, Biostatistics, and vendors. You will drive UAT, testing, and data integration efforts to support successful study conduct and closeout.

The role requires 5–6 years in clinical systems PM with IRT/eCOA experience, strong problem-solving, and excellent communication to align stakeholders and regulatory