Senior Clinical Study Manager

Intuitive is a global leader in robotic-assisted surgery and minimally invasive care. As a Senior Clinical Study Manager, you will develop and execute strategies for US and global first-human-use and pivotal pre-market clinical trials. The ideal candidate will have experience managing premarket studies in the United States and/or experience with multi-national studies and scoping research topics to provide recommendations on clinical trial strategy.

Requirements

• Previous experience managing and implementing pre-market medical device trials
• Significant knowledge of clinical and/or outcomes research study design
• Proven experience in protocol and ICF development, writing clinical section(s) for regulatory submission
• Proven experience in conducting literature searches, reviews and appraisal of the scientific data
• Excellent ability to interact with physicians and other professionals inside and outside the company
• Knowledge of Good Clinical Practice ICH/GCP, FDA regulations, and other applicable regulations, fundamental knowledge of clinical research and monitoring requirements
• Experience negotiating clinical research contracts and budgets
• Ability to work effectively on cross-functional teams
• Ability to manage multiple projects and/or manage different priorities
• Proven communication, presentation and relational skills with high attention to detail and organization
• Ability to learn quickly, tailor to shifting requirements, and self-educate on different surgical specialties as applicable to clinical projects
• Ability to drive project team consisting of CRAs and CTAs and support management with relevant study updates

Benefits

• Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity