Associate Director Clinical Trial Technology, IRT

h3Position Purpose: /h3pThe 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. /ph3This role reports to: Senior Director, Head of Clinical Data Management /h3pThe Associate Director is a matrix leadership role with no direct reports. /ph3Work Environment: /h3p*** 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. /ph3Main Responsibilities and Accountabilities: /h3h3Strategic Implementation Leadership: /h3ulliDevelop 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 /li /ulpProvide strategic oversight of IRT design, randomization approaches, investigational product management, supply strategies, and system implementation to support study objectives, operational efficiency, and patient experience /ph3SME Guidance to Study Teams: /h3ulliProvide 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 /li /ulh3External Partner Engagement: /h3ulliAssess 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 /li /ulh3Communication Training Framework: /h3ulliCreate 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 /li /ulh3Regulatory Compliance Leadership: /h3ulliEnsure 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 /liliAct 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 /liliSupport audits, inspections, and resolution of findings related to IRT systems and processes, ensuring appropriate documentation, traceability, and compliance with applicable regulations and CSL requirements /liliSupport 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 processesbr/and innovations /liliMentor 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 /liliWhen 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 /li /ulh3Minimum Qualifications: /h3ulliBachelor's degree in a scientific discipline, biological sciences, healthcare, information technology, or related field required /lili10+ years of clinical trial technology experience within the pharmaceutical industry, CRO, and/or healthcare technology industry /liliSignificant experience with Interactive Response Technology (IRT), including study design, randomization methodologies, investigational product management, and vendor oversight /liliExperience collaborating with external partners, including CROs and technology vendors /liliDemonstrated knowledge of system validation regulations and guidance for IRT and related clinical technologies /liliProven understanding of clinical supply management principles and the role of IRT in supporting investigational product distribution, dosing, accountability, and inventory management /liliDemonstrated ability to act as an IRT subject matter expert (SME) to study teams and work closely with external partners, providing strategic and technical guidance while fostering strong collaborative relationships /liliDemonstrated ability to teach other functions the basic principles of IRT methodologies necessary to support CSL clinical trials /liliSkilled at independently navigating new or novel indications, study/program approaches, and unique challenges /liliProject management skills including simultaneous management of multiple projects. Possesses excellent planning, time management, and coordination skills /liliAbility to problem solve and use sound judgment in relation to interactions with external parties, timelines, complex clinical programs, and IRT-related risks and issues /liliExperience providing oversight of external vendors and managing IRT-related escalations, risks, and issue resolution /liliThorough understanding of the principles of Clinical Data Management and/or experience as a Clinical Data Manager is a plus /li /ul #J-18808-Ljbffr