IRT Manager Clinical Supply Systems

The IRT Manager, Clinical Supply Systems, is a key member of the Clinical Supply Systems Group whose primary responsibility is supporting clinical studies utilizing an Interactive Response Technology (IRT) system. These systems are also routinely referenced as IVRS, IWRS, RTSM, etc. This group resides within the Clinical Drug Supply and Logistics Department.
The role requires primary subject matter expertise in IRT systems as they will act as the main contact for both internal and external study team members in supporting IRT efforts in a clinical trial. The role collaborates with several functional areas such as clinical trial management, data management, biostatistics, and clinical supply leads, regarding system requirements/specifications, oversight during study conduct, and closeout activities. Must have excellent interpersonal, presentation, and writing skills.

A typical day in this role looks like:

• Essential Functions required for the job. List both technical and managerial requirements if applicable.
• Establishes and maintains oversight of 3rd party IRT vendor.
• Works directly with study teams to gather requirements and ensure IRT system is developed in line with study protocol.
• Develops and manages system deployment timelines for IRT.
• Manages IRT documentation which include but is not limited to: requirements, user guides, training materials, and communication plans.
• Coordinates user acceptance testing.
• Manages the deployment of IRT applications with internal teams and contract vendor.
• Provides guidance related to contracted vendors’ functionality, performance, and processes.
• Works with Clinical Logistics and Biostats on the upload of key information (i.e., subject randomization and kit lists, etc.)
• Oversees routine meetings with contract vendor regarding performance, issues identification/resolution, and risk management.
• Ensure effective training plans for IRT systems are developed for clinical teams and site personnel with the contract vendor.
• If required, attend Investigator Meetings or CRA Trainings to discuss system functionality and requirements.
• May require up to 25% travel

This role may be for you if you have:

• Experience developing IRT systems for clinical trials.
• Working knowledge of the IRT terminology and computer programming terms.
• Through understanding clinical trial protocol and translated for system development.
• Knowledge of ICH/GCP and regulatory guidelines/directives; Disease/therapeutic area knowledge (a plus).
• Understands current and future business trends and information.
• Leadership and negotiation skills; Mentoring/coaching skills.
• Ability to effectively multi-task and prioritize.
• Effective problem-solving skills.
• Written and verbal communication and presentation skills in small and large group settings.
• Project management and organizational skills.
• Computer skills, with competency in MS Office Suite.
• Cross functional and cross-cultural awareness.
• Ability to work in a matrix environment.

In order to be considered qualified for this role, a minimum of a Bachelor’s degree and 6+ years of relevant industry related experience is required.

is required.