Associate Director Clinical Trial Technology, IRT

The Associate Director Clinical Trial Technology, IRT is responsible for implementing clinical trial technology strategy and innovative IRT solutions at the program level across all therapeutic areas and phases of development. This role monitors emerging technologies and industry trends related to Interactive Response Technology (IRT), evaluates their risk/benefit for CSL trials, and ensures solutions are fit for purpose. The Associate Director engages with industry experts, maintains regulatory knowledge, and leads organizational learning to drive the adoption of IRT best practices and standards.

The focus is on cost, operational efficiency, quality, data integrity, investigational product management, randomization strategy, and enhancing the user (site/patient) experience. The position requires close collaboration with internal study teams, Clinical Supply Chain, Biostatistics, and external partners, serving as the IRT subject matter expert (SME) to guide best practices, provide strategic oversight, and ensure successful implementation and governance of IRT solutions.

The Associate Director is a matrix leadership role with no direct reports.

*** This is a hybrid position based onsite at any of the posted locations with a minimum of 3 days onsite weekly. Relocation and mobility assistance are not provided.

• Develop and implement IRT solutions that advance the clinical trial technology strategy in collaboration with Clinical Operations, Clinical Supply Chain, Biostatistics, Data Management, and other partner functions to ensure end-to-end data integrity at both the portfolio and program/study level

Provide strategic oversight of IRT design, randomization approaches, investigational product management, supply strategies, and system implementation to support study objectives, operational efficiency, and patient experience

• Provide feasibility assessments and expert guidance to both insourced and outsourced program and study teams on IRT strategy, design, implementation, and oversight, including randomization methodologies, investigational product supply management, patient dosing workflows, and integration with other clinical technologies, as applicable

• Assess and qualify external service providers and IRT solutions, sharing lessons learned and collaborating with relevant team members and external partners to drive continuous improvement, establish best practices, and ensure effective vendor oversight and governance

• Create and maintain a communication framework for information sharing, training, and feedback with partners at the program study level, driving continuous improvement, adoption of IRT best practices, and organizational learning

• Ensure all IRT solutions meet data quality, regulatory, and compliance requirements, including support for regulatory submissions, and align with CSL SOPs, guidelines, industry best practices, and inspection readiness expectations
• Act as the primary point of contact, both internally and externally (e.g., vendors), for study-related IRT activities, providing strategic guidance, issue management, escalation support, and oversight throughout the study lifecyce
• Support audits, inspections, and resolution of findings related to IRT systems and processes, ensuring appropriate documentation, traceability, and compliance with applicable regulations and CSL requirements
• Support the development and continuous improvement of SOPs, standards, guidance documents, and governance processes related to IRT and broader clinical trial technology activities, and/or participate in cross-functional working groups focused on new processes
  and innovations
• Mentor junior staff; act in an advisory capacity to Clinical Operations colleagues and cross-functional stakeholders within and across therapeutic areas on IRT strategy, best practices, and operational considerations
• When accountable for a set of studies and/or programs, provide oversight and direction for IRT activities, ensuring appropriate delegation, vendor delivery, risk management, inter-program efficiencies, and application of lessons learned across the portfolio

• Bachelor's degree in a scientific discipline, biological sciences,…