IRT Project Manager- FSP, Remote US

The IRT Project Manager is accountable for the client’s study specific Interactive Response Technology (IRT) implementation, ongoing conduct support, closeout and decommission.

Responsibilities

• Provides subject matter expertise, leads study specific implementation, ensures on time delivery, and remediation of support issues.
• 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 escalate issues as needed. · Perform all other duties as needed or assigned.

Requirements

• 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.
• 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

$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.

Benefits

• 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.

Application Deadline

11/30/2026 #LI Remote # LI CS1 Learn more about our EEO & Accommodations request here .