IRT & Clinical Supply Systems Lead (Hybrid)

Regeneron Pharmaceuticals, Inc; Armonk (NY); Hybrid; USD 115,000 - 187,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is looking for a Clinical Supply Systems Manager to support our clinical trials in a hybrid setting.

You will oversee IRT systems, lead cross-functional collaboration with clinical trial management, data management, biostatistics and clinical supply leads, and manage timelines and trainings for investigator meetings and sites. The role requires 4+ years in biotechnology/pharma with IRT experience, strong knowledge of ICH/GCP, and excellent project management,

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.
• International Council for Harmonisation/Good Clinical Practice and regulatory guideline/directive knowledge.
• Microsoft Office Suite competency.
• Understanding of current and future business trends.
• Leadership, negotiation, mentoring and coaching skills.
• Multitasking, prioritisation, problem-solving, project management and organisational skills.
• Written, verbal and small/large-group presentation skills.
• Cross-functional/cross-cultural awareness and matrix-working ability.
• Disease/therapeutic-area knowledge is a plus.

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.
• You bring a collaborative, solution-focused mindset.

Skills

Leadership

Negotiation

Mentoring

Coaching

Multitasking

Prioritisation

Problem-solving

Project management

Communication skills

Cross-cultural awareness

Education

Bachelor’s degree

Eight years’ equivalent experience

Tools

Microsoft Office Suite

Job description

Regeneron Pharmaceuticals, Inc. is looking for a Clinical Supply Systems Manager to support our clinical trials in a hybrid setting.

You will oversee IRT systems, lead cross-functional collaboration with clinical trial management, data management, biostatistics and clinical supply leads, and manage timelines and trainings for investigator meetings and sites. The role requires 4+ years in biotechnology/pharma with IRT experience, strong knowledge of ICH/GCP, and excellent project management,