IRT Project Manager, Remote US

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. 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.

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