IRT Project Manager, Remote US

Fortrea•Durham, NC

1d•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 timely delivery, and supports remediation of issues. The Project Manager works with internal cross-functional stakeholders and vendors to manage IRT study delivery, testing, integrations, documentation, quality, and governance.

Requirements

University or college degree, preferably in life sciences, health sciences, information technology, or a related subject, or certification in allied health professions from an appropriate accredited institution; relevant and equivalent experience may be considered in lieu of education.
Fluency 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, including 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 contribute to shared goals.

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 completion and approval of IRT documentation, including specifications.
Serve as the primary vendor contact for study-specific matters.
Ensure compliance with relevant regulations, including GxPs and ICH E6.
Guide the IRT implementation team 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 scripts.
Facilitate UAT execution, coordinate issue resolution with vendors, and ensure appropriate documentation.
Define and oversee data exchange requirements between IRT and other systems; 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, including root causes, corrective actions, and preventive measures.
Advise on post-launch system changes to ensure alignment with study and program needs.
Manage study-specific IRT contracts, budgets, and change orders.
Support the Global IRT Lead with process governance and standardization; maintain consistency in 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 clinical, technology, quality, regulatory, and outsourcing stakeholders.
Provide regular updates to the Line Manager and escalate issues as needed.
Perform other duties as needed or assigned.