IRT Project Manager

Job not on LinkedIn

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🇺🇸 United States – Remote

💵 $110k - $125k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Lead study-specific IRT Implementation Teams and coordinate cross-functional stakeholders and vendors • Create and manage IRT-related timelines and deliverables • Review vendor-written specifications and integration documents • Plan, facilitate, and lead IRT study review meetings • Ensure completion and approval of IRT documentation, including specifications • Serve as the primary point of contact for the IRT vendor • Ensure compliance with GxPs and ICH E6 • Provide guidance on optimal system utilization and IRT best practices • Define and complete documentation for vendor scope-of-work requests • Review and provide expert input on User Requirement Specifications and 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, and ensure documentation • Define and oversee data exchange requirements and integration solutions • Manage testing for efficient and error-free data transfers • Guide study teams on site-initiated data changes and vendor implementation • Facilitate collection of closeout deliverables and manage decommissioning activities • Maintain study-specific issue and risk logs, including root causes and corrective/preventive actions • Advise on post-launch system changes • Manage IRT contracts, budgets, and change orders • Support IRT process governance and standardization • Maintain consistency in IRT terminology, functionality, and reporting • Assist with metrics collection and reporting • Recommend improvements to quality procedures and best practices • Conduct or develop IRT-related training • Foster collaboration across internal stakeholders • Provide regular updates to the Line Manager and escalate issues as needed • Perform other assigned duties

🎯 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 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

🏖️ Benefits

• Medical insurance • Dental insurance • Vision insurance • Life insurance • Short-term disability (STD) insurance • Long-term disability (LTD) insurance • 401(k) • Paid time off (PTO) or flexible time off (FTO) • Company bonus where applicable

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