TEMP - IRT Manager, Clinical Supply Systems

Location
Tarrytown, NY, United States
Posted
Oct 17, 2020
Ref
20708BR
Required Education
Bachelors Degree
Position Type
Contract
The Temp - IRT Manager, Clinical Supply Systems, is primarily responsible for 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, as we continuously improve our systems. He/she must have excellent interpersonal, presentation, and writing skills.

For the Temp - IRT Manager, CSS a typical day might include the following:
  • Interacting with and managing 3rd Party IRT vendor(s)
  • Working directly with study teams to gather requirements and ensure the IRT system is developed in line with study protocol.
  • Developing and handling system deployment timelines for IRT.
  • Responsibility for IRT documentation which include but is not limited to: requirements, user guides, training materials, and communication plans.
  • Coordinating user acceptance testing.
  • Leading the deployment of IRT applications with internal teams and contract vendor.
  • Leading meetings with contract vendor regarding performance, issues identification/resolution, and risk management.
  • Ensuring effective training plans for IRT systems are developed for clinical teams and site personnel with the contract vendor.
This role may be for you if you have:
  • Experience developing IRT systems for clinical trials.
  • Solid understanding of IRT terminology and computer programming terms.
  • Knowledge of ICH/GCP and regulatory guidelines/directives; Disease/therapeutic area knowledge (a plus).
  • An understanding of current and future business trends and information.
  • Leadership skills; Mentoring and coaching skills.
  • Project management and organizational skills.
  • Cross functional and cross-cultural awareness
To be considered for this opportunity you have:

A Bachelor's Degree in IT, Computer Science preferred.

Minimum 5 years of relevant experience in the biotechnology/pharmaceutical industry, with minimum 3 years with direct IRT systems experience.

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 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 maternity 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.