[Hiring] Senior Clinical Study Manager @Intuitive

Role Description

This position requires a candidate with extensive experience helping evidence generation strategy and execution of clinical studies. The Clinical Study Manager-4 (CSM IV) role will develop and execute strategies for clinical and outcomes research studies to help regulatory approvals and key strategic evidence initiatives. As a member of the Clinical Affairs team, this role will be accountable for working with key stakeholders to design and develop clinical protocols and execute clinical studies (pre-market or post-market studies), with minimal supervision.

• Drive the progress of the trial during site selection, site start-up, enrollment, and follow-up.
• Provide guidance to monitors about monitoring needs and oversee compliance work on the study.
• Take a leadership role in external communication with investigators and study teams.
• Manage premarket studies in the United States and utilize resources to research and scope research topics.
• Review, interpret, and summarize clinical literature.

Qualifications

• Previous experience implementing, helping, and managing 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 scientific data.
• Excellent ability to interact with physicians and other professionals inside and outside the company.
• Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations.
• Experience negotiating clinical research contracts and budgets.
• Must be able to work effectively on cross-functional teams.
• Must be able to travel 25-40% or based on business requirements.
• Must be able 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.
• Ability to drive project team consisting of CRAs and CTAs and support management with relevant study updates.
• Exhibits solid work ethic to help meet tight timelines or multiple projects when necessary with a problem-solving mindset.

Requirements

• Minimum advanced degree in a scientific/bioengineering field (M.S., Ph.D. or M.D.) with a minimum of 5 years of experience in clinical research, or Bachelor’s degree in a scientific/bioengineering field with a minimum of 8 years of experience in clinical research, or a minimum of 10 years of experience in clinical research with relevant training.

Preferred Skills and Experience

• Accustomed to working in a hospital environment, experience working with nurses and surgeons preferred.
• Knowledge of statistics, statistical methods, and design of experiment is highly preferred.

Benefits

• Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity.
• Remote work opportunities; employees will come onsite when requested by the leader.