IRT Project Manager- FSP

Accountabilities: Lead study-specific IRT implementation teams, coordinating stakeholders across Clinical Trial Supply, Global Clinical Operations, Biostatistics, Data Management, and external vendors. Develop, manage, and monitor IRT project timelines, deliverables, and study milestones. Organize internal reviews of vendor-developed specifications and integration documents, and lead study review meetings. Ensure the completion, accuracy, and approval of IRT documentation, including system specifications and implementation materials. Act as the primary point of contact for IRT vendors on study-specific matters and provide guidance on effective system utilization. Ensure IRT activities comply with applicable regulations and standards, including GxP requirements and ICH E6. Provide subject matter expertise on IRT best practices and share lessons learned across project teams. Define and prepare initial documentation for vendor scope-of-work requests, and review User Requirement Specifications (URS) and other IRT-related documentation. Review and approve User Acceptance Testing (UAT) schedules to ensure alignment with URS requirements. Develop study-specific IRT test plans and scripts, facilitate UAT execution, coordinate defect resolution with vendors, and ensure testing activities are properly documented. Define and oversee data exchange requirements between IRT and other systems, working with stakeholders to determine suitable integration solutions. Coordinate initial and ongoing integration testing to support accurate, efficient, and reliable data transfers. Guide study teams through site-initiated data changes and coordinate related vendor implementation activities. Coordinate the collection of vendor closeout deliverables and oversee study-specific IRT closeout activities. Maintain study issue and risk logs, documenting root causes, corrective actions, and preventive measures. Advise on post-launch system changes to ensure continued alignment with study and program requirements. Manage study-specific IRT contracts, budgets, and change orders. Support the Global IRT Lead with process governance and standardization, maintaining consistency in terminology, functionality, and reporting across studies. Contribute to metrics collection and reporting, recommend improvements to quality procedures and best practices, and develop or deliver IRT-related training for internal teams. Foster collaboration across Clinical Trial Supplies, eClinical Technology, Global Clinical Operations, Biostatistics, Data Management, Clinical Quality, Regulatory, and Outsourcing teams. Provide regular progress updates to the Line Manager, escalate issues when necessary, and undertake other assigned responsibilities. Requirements University or college degree, preferably in life sciences, health sciences, information technology, or a related discipline, or a certification in an allied health profession from an appropriately accredited institution. Equivalent relevant experience may be considered in place of formal education. 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. Demonstrated experience managing outsourced technology vendors and collaborating with sponsors and cross-functional project teams. Strong understanding of the clinical trial lifecycle, including system implementation, data flows, regulatory compliance, and Trial Master File (TMF) documentation. Knowledge of IRT implementation practices, system validation, requirements documentation, and integrations between clinical systems. Strong problem-solving skills, with a proactive, analytical, and detail-oriented approach to issue resolution and system validation. Excellent written and verbal communication skills, with the ability to engage stakeholders, prepare clear documentation, and deliver effective project updates. Fluent English, both written and spoken. 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 manage competing demands and meet tight deadlines without compromising quality. Self-motivation, accountability, and ownership of assigned responsibilities. A cooperative, team-oriented mindset and willingness to support colleagues and contribute to shared objectives. Benefits Annual salary range of $110,000–$125,000, with offers determined by relevant skills and experience, degrees or certifications, internal equity, and market data. Comprehensive benefits eligibility for regular full-time or part-time employees working at least 20 hours per week. Medical, dental, and vision coverage. Life insurance. Short-term and long-term disability coverage. 401(k) retirement plan. Paid time off (PTO) or flexible time off (FTO). Company bonus, where applicable. Remote work arrangement within the United States.