Clinical Study Lead – Medical Devices & Regulation

Intuitive; Oregon; Hybrid; USD 120,000 - 180,000; Full time

Job summary

Intuitive Surgical in the United States, Oregon, seeks a Clinical Study Manager IV to develop and execute strategies for clinical and outcomes research to support regulatory approvals and evidence initiatives. You will design protocols, manage sites, budgets, and collaborate with CRAs, CTAs, and biostatisticians to deliver high-quality data. The ideal candidate has 5+ years in medical device clinical research and experience with premarket/postmarket studies.

Qualifications

• Advanced degree in science or bioengineering required.
• Experience in protocol and ICF development for regulatory submissions.
• Strong communication and cross-functional collaboration.

Responsibilities

• Lead assigned clinical research activities.
• Coordinate with CRAs and CTAs and biostatisticians.
• Oversee site selection, initiation, recruitment projections, and study documents.
• Ensure compliance with GCP and regulatory requirements.
• Prepare clinical study reports and support publications.

Skills

Clinical research

Study design

Protocol development

ICF development

Contract negotiation

Cross-functional collaboration

Education

Advanced degree in scientific/bioengineering field

Bachelor’s degree with 8+ years clinical research experience

Tools

EDC systems

Job description

Intuitive Surgical in the United States, Oregon, seeks a Clinical Study Manager IV to develop and execute strategies for clinical and outcomes research to support regulatory approvals and evidence initiatives. You will design protocols, manage sites, budgets, and collaborate with CRAs, CTAs, and biostatisticians to deliver high-quality data. The ideal candidate has 5+ years in medical device clinical research and experience with premarket/postmarket studies.