IRT Lead, Clinical Trials Configuration; CTC

Job Description

The IRT Lead within the Clinical Trials Configuration (CTC) group is responsible for the strategic oversight, implementation, and operational delivery of Interactive Response Technology (IRT/IxRS) in support of Takeda clinical studies.

This role partners closely with study teams, CROs, vendors, Clinical Supplies, and cross‑functional stakeholders to ensure clinical technology solutions are implemented efficiently, compliantly, and with high quality. The IRT Lead serves as a subject matter expert for IRT and related clinical technologies, providing leadership across technology strategy, vendor oversight, system lifecycle management, inspection readiness, and continuous process improvement.

Reporting into Clinical Trials Configuration Leadership this role helps ensure that study‑level technology solutions align with Takeda SOPs, policies, governance models, business objectives, and regulatory requirements, including ICH‑GCP and applicable FDA regulations.

• Develop and execute strategy for IRT technology selection, deployment, and support across clinical studies in alignment with established Takeda SOPs, policies, and governance models.
• Serve as a trusted advisor to study teams in the selection, design, and implementation of IRT solutions that support study and program objectives.
• Identify and recommend innovative and cost‑effective IRT solutions to meet clinical program needs.
• Act as a business change agent to support adoption of new capabilities, technologies, and business processes.

• Lead oversight of the system delivery lifecycle for IRT, including planning, implementation, validation support, deployment strategies, training, issue management, change management, and closeout.
• Ensure new integrations, enhancements, and upgrades to IRT platforms are implemented in a GCP‑compliant manner and provide intended functionality.
• Support development and maintenance of processes and documentation required to operate and sustain clinical trial technology solutions.
• Confirm inspection readiness, archival readiness, and completeness of applicable Clinical Technology TMF documentation and participate in inspections as IRT SME.

• Lead study‑level oversight of IRT vendors, CROs, and other third‑party partners to ensure milestone achievement, quality delivery, and alignment with study requirements.
• Serve as the primary point of contact for clinical technology vendors when collaboration, issue resolution, or escalation is needed.
• Contribute to management of vendor partnerships and confirm contractual assumptions captured in study statements of work.

• Act as a process expert for clinical technology operational and oversight models.
• Ensure all activities are conducted in accordance with ICH‑GCP, FDA regulations, industry standards, quality principles, and Takeda requirements.
• Confirm inspection readiness, archival readiness, and completeness of applicable Clinical Technology TMF documentation and participate in inspections as IRT SME.
• Track key study deliverables, milestones, metrics, and risks, and contribute to development of appropriate mitigation plans.

• Collaborate with internal and external stakeholders, including study teams, Clinical Supplies, Data Management, CROs, and vendors, to ensure successful implementation and support of IRT solutions.
• Manage or oversee a small group of contractors supporting day‑to‑day IRT platform administration and operations.
• Contribute to development and maintenance of clinical technology best practices across the organization.
• Perform other duties as assigned.

• BS/BA required
• MS preferred
• Preferred area of study: health‑related, life sciences, or technology‑related disciplines

• Minimum of 6–8 years of drug development experience
• Strong experience supporting or managing IRT/IxRS implementation for clinical studies or development programs
• Solid understanding of clinical trial documentation and processes
• Experience…