IRT Project Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead IRT Implementation Teams specific to studies and coordinate with cross-functional stakeholders and vendors.

• Develop and oversee timelines and deliverables associated with IRT.

• Evaluate vendor-generated specifications and integration documentation.

• Organize, facilitate, and lead review meetings for IRT studies.

• Ensure the completion and approval of IRT documentation, which includes specifications.

• Act as the main point of contact for the IRT vendor.

• Guarantee compliance with GxPs and ICH E6 standards.

• Offer guidance on optimal utilization of the system and best practices for IRT.

• 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.

• Develop study-specific IRT test plans and test scripts.

• Facilitate UAT execution, coordinate issue resolution, and ensure proper documentation.

• Define and manage data exchange requirements and integration solutions.

• Supervise testing for efficient and accurate data transfers.

• Guide study teams regarding site-initiated data changes and vendor implementation.

• Oversee the collection of closeout deliverables and manage decommissioning activities.

• Maintain issue and risk logs specific to studies, including root causes and corrective/preventive actions.

• Advise on system changes after launch.

• Manage contracts, budgets, and change orders related to IRT.

• Support governance and standardization of IRT processes.

• Ensure consistency in IRT terminology, functionality, and reporting.

• Assist in the collection and reporting of metrics.

• Recommend enhancements to quality procedures and best practices.

• Conduct or develop training related to IRT.

• Promote collaboration among internal stakeholders.

• Provide regular updates to the Line Manager and escalate issues as necessary.

• Carry out other assigned responsibilities.

⛳️ Requirements

• A university or college degree in life sciences, health sciences, information technology, or related fields is preferred, or a certification in allied health professions from a recognized accredited institution.

• Fortrea may take relevant and equivalent experience into account instead of educational qualifications.

• Proficiency in English, both written and spoken.

• 5–6 years of pertinent experience in clinical systems project management, particularly focused on IRT and/or eCOA platforms.

• Practical experience in User Acceptance Testing (UAT), including planning, execution, defect tracking, and support during system go-live.

• Proven capability to manage outsourced technology vendors and collaborate effectively with sponsors and cross-functional teams.

• Strong problem-solving abilities with a proactive, detail-oriented approach to issue resolution and system validation.

• Excellent oral and written communication skills for engaging stakeholders, documentation, and reporting.

• Comprehensive understanding of the clinical trial lifecycle, including system implementation, data flow, regulatory compliance, and TMF documentation.

• Capacity to work independently and collaboratively in a dynamic, team-oriented environment with minimal supervision.

• Strong time management and prioritization skills, with the ability to meet tight deadlines while ensuring high-quality standards.

• Demonstrated self-motivation, accountability, and ownership of assigned responsibilities.

• A cooperative and team-oriented mindset, with a willingness to assist peers and contribute to collective 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