Associate Director, IRT & Clinical Trial Technology

CSL Plasma; King of Prussia (PA); Hybrid; USD 180.000 - 230.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

IRT expertise

Vendor oversight

Project management

Cross-functional leadership

Regulatory knowledge

Training & mentoring

Ausbildung

Bachelor's degree in science

Jobbeschreibung

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.