Hybrid IRT & Clinical Trial Systems Manager

Regeneron Pharmaceuticals, Inc.; Armonk (NY); Hybrid; USD 115.000 - 187.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Supply Systems Manager to support IRT systems within a hybrid setup across multiple locations. You will collaborate with clinical trial teams, data management, biostatistics and supply leads to ensure smooth trial execution.

You will lead IRT deployment, vendor oversight, testing coordination and training development, demonstrating leadership and cross-functional collaboration in a fast-moving, science-driven environment.

Qualifikationen

• 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.
• 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.

Aufgaben

• 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.

Kenntnisse

IRT systems experience

Leadership

Project management

Negotiation

Communication

Problem solving

Presentation skills

Cross-functional collaboration

Industry knowledge

Microsoft Office

Ausbildung

Bachelor’s degree or equivalent experience

Jobbeschreibung

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Supply Systems Manager to support IRT systems within a hybrid setup across multiple locations. You will collaborate with clinical trial teams, data management, biostatistics and supply leads to ensure smooth trial execution.

You will lead IRT deployment, vendor oversight, testing coordination and training development, demonstrating leadership and cross-functional collaboration in a fast-moving, science-driven environment.