Clinical IRT & Supply Systems Lead (Hybrid)

BioSpace; Armonk (NY); Hybrid; USD 115,000 - 187,000; Full time

Job summary

Regeneron is seeking a Clinical Supply Systems Manager to support our IRT systems within a Hybrid work setting, collaborating with clinical trial management, data management, biostatistics and clinical supply leads. The role involves leading IRT study-team activities from protocol requirements through closeout and coordinating testing, training, and vendor interactions to ensure smooth study operations.

The position requires a Bachelor’s degree (or eight years’ equivalent experience), 4+ years

Qualifications

• 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.
• ICH-GCP and regulatory guideline knowledge.
• MS Office competency.

Responsibilities

• 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.

Skills

IRT systems experience

Leadership

Negotiation

Mentoring

Coaching

Cross-functional collaboration

Presentation skills

Project management

Multitasking

Prioritisation

Problem solving

Organisation

ICH-GCP knowledge

Therapeutic area knowledge

Education

Bachelor's degree

Tools

Microsoft Office

Job description

Regeneron is seeking a Clinical Supply Systems Manager to support our IRT systems within a Hybrid work setting, collaborating with clinical trial management, data management, biostatistics and clinical supply leads. The role involves leading IRT study-team activities from protocol requirements through closeout and coordinating testing, training, and vendor interactions to ensure smooth study operations.

The position requires a Bachelor’s degree (or eight years’ equivalent experience), 4+ years