Associate Director Clinical Trial Technology, IRT

CSL Plasma; King of Prussia (PA); Hybride; USD 180 000 - 230 000; Plein temps

Résumé du poste

CSL Plasma seeks an Associate Director of Clinical Trial Technology, IRT, to lead strategy and implementation of Interactive Response Technology across programs. You will shape IRT solutions, assess new technologies, and drive governance, data integrity, and patient/site experience.

This hybrid role requires collaboration with Clinical Operations, Clinical Supply Chain, Biostatistics, and external partners.

Qualifications

• Bachelor's degree in a scientific discipline required.
• 10+ years of clinical trial technology experience in the pharmaceutical industry, CRO, or healthcare technology.
• Significant experience with Interactive Response Technology (IRT), including study design, randomization, product management, and vendor oversight.
• Experience collaborating with external partners, including CROs and technology vendors.
• Knowledge of system validation regulations and guidance for IRT and related technologies.
• Understanding of clinical supply management principles and the role of IRT in distribution, dosing, accountability, and inventory management.

Responsabilités

• Strategic Implementation & Leadership: Develop and implement IRT solutions across portfolio and program levels.
• SME Guidance to Study Teams: Provide feasibility assessments and expert guidance on IRT strategy, design, and oversight.
• External Partner Engagement: Assess and qualify external providers and drive continuous improvement.
• Communication & Training Framework: Create and maintain communication and training frameworks with partners.
• Regulatory & Compliance Leadership: Ensure data quality, regulatory compliance, SOP alignment, audits support, and governance of IRT activities.
• Mentor junior staff and provide advisory support to Clinical Operations and cross-functional teams.
• Oversee IRT activities across multiple studies to ensure delegation, vendor delivery, risk management, and lessons learned.

Connaissances

IRT expertise

Vendor oversight

Project management

Cross-functional leadership

Regulatory knowledge

Training & mentoring

Formation

Bachelor's degree in science

Description du poste

Position Purpose:

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.

Work Environment:

*** 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.

Main Responsibilities and Accountabilities:

Strategic Implementation & Leadership:

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.

SME Guidance to Study Teams:

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.

External Partner Engagement:

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.

Communication & Training Framework:

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.

Regulatory & Compliance Leadership:

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 lifecycle. 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.

Minimum Qualifications:

• Bachelor's degree in a scientific discipline, biological sciences, healthcare, information technology, or related field required
• 10+ years of clinical trial technology experience within the pharmaceutical industry, CRO, and/or healthcare technology industry
• Significant experience with Interactive Response Technology (IRT), including study design, randomization methodologies, investigational product management, and vendor oversight
• Experience collaborating with external partners, including CROs and technology vendors
• Demonstrated knowledge of system validation regulations and guidance for IRT and related clinical technologies
• Proven understanding of clinical supply management principles and the role of IRT in supporting investigational product distribution, dosing, accountability, and inventory management
• Demonstrated 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
• Demonstrated ability to teach other functions the basic principles of IRT methodologies necessary to support CSL clinical trials
• Skilled at independently navigating new or novel indications, study/program approaches, and unique challenges
• Project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management, and coordination skills
• Ability to problem solve and use sound judgment in relation to interactions with external parties, timelines, complex clinical programs, and IRT-related risks and issues
• Experience providing oversight of external vendors and managing IRT-related escalations, risks, and issue resolution
• Thorough understanding of the principles of Clinical Data Management and/or experience as a Clinical Data Manager is a plus