Senior Clinical Study Lead – Regulatory Evidence

Intuitive; Sunnyvale (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Intuitive is seeking a Senior Clinical Study Manager to lead and execute clinical and outcomes research studies in support of regulatory submissions and strategic evidence initiatives. The role involves collaboration with CRAs, CTAs, data management and biostatisticians, with leadership responsibilities across trial phases.

The ideal candidate will drive site selection, monitoring, and reporting while ensuring compliance with GCP, regulatory requirements, and company SOPs.

Qualifications

• Extensive experience supporting evidence generation strategy in clinical studies.
• Experience with IDE/510k or PMA submissions.
• Ability to design protocols and execute pre-market or post-market studies.
• Experience coordinating with CRAs, CTAs, data management and biostatisticians.

Responsibilities

• Lead assigned clinical research activities.
• Collaborate with investigators, KOLs to develop study design and protocols.
• Prepare study documents (protocols, CRFs, ICFs) and IRB submissions.
• Manage site selection, recruitment projections, and study budgeting.
• Monitor regulatory compliance and data quality per GCP.
• Conduct source data verification and data listings.
• Support audits and sponsor audit readiness.
• Negotiate contracts and budgets with sites and vendors.
• Track study progress and prepare status reports.
• Assist in development of clinical study reports and publications.
• Mentor junior project staff and provide guidance to CRAs/CTAs.
• Ensure adherence to SOPs and regulatory guidelines.

Job description

Intuitive is seeking a Senior Clinical Study Manager to lead and execute clinical and outcomes research studies in support of regulatory submissions and strategic evidence initiatives. The role involves collaboration with CRAs, CTAs, data management and biostatisticians, with leadership responsibilities across trial phases.

The ideal candidate will drive site selection, monitoring, and reporting while ensuring compliance with GCP, regulatory requirements, and company SOPs.