Senior Clinical Study Leader — Evidence & Regulatory Strategy

Intuitive; Sunnyvale (CA); Presencial; USD 140 000 - 210 000; Tempo integral

Resumo da oferta

Intuitive is seeking a Clinical Study Manager-4 to develop and execute strategies for clinical and outcomes research. You will lead studies (pre- or post-market), design protocols, and collaborate with CRAs, CTAs, data management, and biostatisticians to ensure robust evidence for regulatory approvals.

The role requires guiding external investigators, managing timelines and budgets, and ensuring compliance with GCP and US/OUS guidelines. Strong leadership and strategic thinking are essential.

Qualificações

• Experience leading clinical studies from design to execution.
• Ability to manage site selection, initiation, enrollment and follow-up.
• Strong collaboration with CRAs, CTAs and biostatisticians.

Responsabilidades

• Lead assigned clinical research activities.
• Partner with investigators and KOLs to develop study design and protocols.
• Oversee site selection, recruitment projections, and study docs (protocols, CRFs, ICFs).
• Ensure studies run on schedule and within budget with high quality and compliance.
• Conduct site visits and monitoring per the monitoring plan.
• Support regulator readiness and sponsor audits.

Conhecimentos

Clinical study management

Regulatory compliance

IRB submissions

Mentoring/guidance

Cross-functional collaboration

Biostatistics collaboration

Ferramentas

EDC systems

Descrição da oferta de emprego

Intuitive is seeking a Clinical Study Manager-4 to develop and execute strategies for clinical and outcomes research. You will lead studies (pre- or post-market), design protocols, and collaborate with CRAs, CTAs, data management, and biostatisticians to ensure robust evidence for regulatory approvals.

The role requires guiding external investigators, managing timelines and budgets, and ensuring compliance with GCP and US/OUS guidelines. Strong leadership and strategic thinking are essential.