Associate Director, Clinical Trial Technology, IRT

CSL

. Implement clinical trial technology strategy and innovative IRT solutions across therapeutic areas and development phases .

Posted 10/8/2026full-timeKing of Prussia • Pennsylvania • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Interactive Response Technology (IRT) implementation and management, ensuring compliance with regulatory standards and best practices. Capable of leading cross-functional teams and mentoring junior staff while managing multiple clinical trial projects effectively.

Highest-signal resume keywords

Interactive Response Technology (IRT)Clinical Trial Technology ExperienceProject Management SkillsRegulatory Compliance KnowledgeVendor Oversight Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Study DesignRandomization MethodologiesInvestigational Product ManagementSystem Validation RegulationsClinical Supply Management PrinciplesIRT MethodologiesSOP DevelopmentRisk ManagementData Quality AssuranceContinuous Improvement Strategies

Soft Skills

Excellent PlanningTime ManagementCoordination SkillsProblem SolvingSound Judgment

Industry Keywords

Pharmaceutical IndustryHealthcare TechnologyCRO CollaborationClinical OperationsRegulatory Submissions

About the role

Key responsibilities & impact

Implement clinical trial technology strategy and innovative IRT solutions across therapeutic areas and development phases
Monitor emerging IRT technologies and industry trends; evaluate risk/benefit and ensure solutions are fit for purpose
Lead organizational learning and adoption of IRT best practices and standards
Provide strategic oversight of IRT design, randomization, investigational product management, supply strategies, and system implementation
Advise insourced and outsourced study teams on IRT strategy, design, implementation, and oversight
Assess and qualify external service providers and IRT solutions; collaborate with vendors to drive continuous improvement
Create and maintain communication, training, and feedback frameworks
Ensure IRT solutions meet data quality, regulatory, compliance, SOP, and inspection-readiness requirements
Serve as primary internal and external point of contact for study-related IRT activities
Support audits, inspections, regulatory submissions, and resolution of IRT-related findings
Develop and improve SOPs, standards, guidance documents, and governance processes
Mentor junior staff and advise Clinical Operations and cross-functional stakeholders
Oversee IRT activities across assigned studies/programs, including delegation, vendor delivery, risk management, and lessons learned
Report to the Senior Director, Head of Clinical Data Management, in a matrix leadership role with no direct reports

Requirements

What you’ll need

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 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) and provide strategic and technical guidance
Demonstrated ability to teach other functions the basic principles of IRT methodologies
Ability to navigate new or novel indications, study/program approaches, and unique challenges independently
Project management skills, including simultaneous management of multiple projects
Excellent planning, time management, and coordination skills
Ability to problem solve and use sound judgment in 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

Benefits

Comp & perks

Benefits information provided via CSL's "How CSL Supports Your Well-being" resource
Hybrid work arrangement
Inclusion and belonging initiatives
Reasonable accommodation for applicants with disabilities