IRT Project Manager, Remote US

Fortrea•Durham, CA

2d•$110,000 - $125,000•Remote

About The Position

The IRT Project Manager is accountable for client study-specific Interactive Response Technology (IRT) implementation, ongoing conduct support, closeout, and decommissioning. The role provides subject matter expertise, leads study-specific implementation, ensures on-time delivery, and supports remediation of issues. It manages IRT-related timelines and deliverables, coordinates cross-functional implementation teams and vendors, oversees specifications and documentation, and serves as the primary vendor contact for study-specific matters. The position supports compliance with relevant regulations, guides teams on effective IRT use, and manages user acceptance testing, integrations, data exchanges, post-launch changes, issue and risk logs, vendor contracts, budgets, and change orders. It also supports process governance and standardization, metrics and reporting, quality improvements, training, cross-functional collaboration, and regular updates to the Line Manager.

Requirements

University or college degree in a relevant area, or certification in allied health professions from an appropriate accredited institution; relevant and equivalent experience may be considered in lieu of education.
Fluent in written and spoken English.
5–6 years of relevant experience in clinical systems project management, with a strong focus on IRT and/or eCOA platforms.
Hands-on experience with 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 and a proactive, 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.
Cooperative, team-oriented mindset and willingness to support peers and shared goals.

Nice To Haves

A degree in life sciences, health sciences, information technology, or a related subject is preferred.

Responsibilities

Lead study-specific IRT implementation teams and coordinate cross-functional stakeholders and vendors.
Create and manage IRT-related timelines and deliverables.
Conduct internal reviews of vendor-written specifications and integration documents.
Plan, facilitate, and lead IRT study review meetings.
Ensure IRT documentation, including specifications, is completed and approved.
Serve as the primary contact for IRT vendors on study-specific matters.
Ensure compliance with relevant regulations, including GxPs and ICH E6.
Guide implementation teams on optimal system utilization and share IRT best practices and lessons learned.
Define and complete initial documentation for vendor scope-of-work requests.
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 vendor issue resolution, and ensure appropriate documentation.
Define and oversee data-exchange requirements between IRT and other systems, and collaborate on integration solutions.
Manage initial and ongoing testing to ensure efficient, error-free data transfers.
Guide study teams on site-initiated data changes and vendor implementation.
Facilitate collection of IRT vendor closeout deliverables.
Maintain study-specific issue and risk logs, documenting root causes, corrective actions, and preventive measures.
Advise on post-launch system changes to align 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 with 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 other duties as needed or assigned.