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.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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Regeneron New York, New York, USA Office
81 Columbia Turnpike, Rensselaer, New York, New York, United States, 12144
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