Clinical Supply Systems Lead (IRT & Trials)

Regeneron Pharmaceuticals, Inc.; Troy (MI); Híbrido; USD 110.000 - 180.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Supply Systems Manager to join the Clinical Supply Systems Group in a hybrid setting, supporting clinical trials with IRT systems and collaborating across clinical operations, data management, biostatistics and supply leads.

You will lead IRT study-team support from protocol-aligned requirements through conduct and closeout, oversee vendor performance, manage deployment timelines with internal teams and vendors, and maintain training

Formación

• Bachelor’s degree or eight years’ equivalent experience.
• Four years’ biotechnology/pharmaceutical experience, including two directly with IRT systems.
• Clinical-trial IRT development experience, protocol interpretation and IRT/programming terminology knowledge.

Responsabilidades

• Lead IRT study-team support from protocol-aligned requirements through conduct and closeout.
• Oversee vendor functionality, processes and performance through routine issue-resolution and risk-management meetings.
• Manage deployment timelines and application launches with internal teams and vendors.
• Maintain requirements, user guides, training materials and communication plans.
• Coordinate user acceptance testing.
• Coordinate randomisation and kit-list uploads with Clinical Logistics and biostatistics.
• Develop vendor-supported clinical-team and site training, presenting functionality and requirements at investigator meetings or clinical research associate training when required.

Conocimientos

IRT systems

Leadership

Clinical trial management

Regulatory knowledge

Vendor management

Microsoft Office

Educación

Bachelor’s degree

Herramientas

Microsoft Office

Descripción del empleo

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Supply Systems Manager to join the Clinical Supply Systems Group in a hybrid setting, supporting clinical trials with IRT systems and collaborating across clinical operations, data management, biostatistics and supply leads.

You will lead IRT study-team support from protocol-aligned requirements through conduct and closeout, oversee vendor performance, manage deployment timelines with internal teams and vendors, and maintain training