Hands-On IRT Lead for Global Clinical Trials

Planet Pharma; California; Híbrido; USD 90 000 - 103 000; Tempo integral

Resumo da oferta

Planet Pharma is seeking an IRT Lead to own design, build, implementation, and lifecycle management of IRT/RTSM systems across Phase I-IV trials. The role ensures patient randomization and investigational product handling runs smoothly at the study level, while also building templates, governance, and best practices to scale across trials.

The position is an individual contributor contract involving collaboration with internal teams and external vendors, with end-to-end responsibility for IRT

Qualificações

• Bachelor’s degree in life sciences, engineering, supply chain, information systems, or related field.
• 5+ years in clinical supply chain or clinical operations with hands-on IRT/RTSM ownership across multiple studies.
• Experience delivering end-to-end IRT builds: specs, testing, go-live, change control, close-out.

Responsabilidades

• Serve as project manager for IRT on assigned trials, leading study builds from kickoff to close-out.
• Translate protocols into URS, confirm randomization design, visit schedules, dosing regimens, and supply configuration.
• Liaise with external IRT vendors, manage timelines and deliverables, and oversee study-specific module configurations.
• Develop test plans with IT and orchestrate UAT covering URS requirements.

Conhecimentos

Project management

IRT/RTSM ownership

Vendor management

Cross-functional collaboration

GCP/regulatory familiarity

Formação académica

Bachelor’s degree in life sciences or related field

Ferramentas

IRT platforms

EDC/CTMS/ERP integrations

Descrição da oferta de emprego

Planet Pharma is seeking an IRT Lead to own design, build, implementation, and lifecycle management of IRT/RTSM systems across Phase I-IV trials. The role ensures patient randomization and investigational product handling runs smoothly at the study level, while also building templates, governance, and best practices to scale across trials.

The position is an individual contributor contract involving collaboration with internal teams and external vendors, with end-to-end responsibility for IRT