Senior Clinical Study Manager

Intuitive Surgical seeks a senior clinical study manager to lead evidence generation and oversee pre-market and post-market clinical research studies. The role involves protocol development, site management, regulatory compliance, and cross-functional collaboration to support strategic research initiatives and regulatory submissions.

Responsibilities

• Lead clinical research activities from site selection through enrollment and follow-up phases
• Develop study protocols, case report forms, informed consents, and clinical trial agreements
• Conduct site qualification, initiation, monitoring, and close-out visits to ensure compliance
• Manage data integrity through source data verification and electronic data capture oversight
• Collaborate with biostatisticians to analyze data and develop clinical study reports and publications

Requirements

• Experience managing medical device clinical trials in the United States
• Strong knowledge of clinical and outcomes research study design methodologies
• Demonstrated expertise in protocol development and regulatory submission writing
• Proficiency in literature searches, critical appraisal, and scientific data synthesis
• Knowledge of ICH/GCP guidelines and applicable clinical research regulations
• Experience negotiating clinical research contracts and managing study budgets
• Excellent communication skills with physicians, investigators, and internal stakeholders