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.
As the Mgr of Clinical Supply System, a typical day might include the following:
• 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 might be a fit 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
To be considered for this opportunity, you must have a Bachelor’s degree (IT/Computer Science preferred) and at least 5 years of relevant experience in the biotechnology/pharmaceutical industry, with minimum 3 years working in an IRT environment.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.