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.

This role reports to:
Senior Director, Head of Clinical Data Management 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…