Senior Clinical Study Manager

Intuitive•Sunnyvale, CA

21h

About The Position

The Senior Clinical Study Manager (Clinical Study Manager IV) develops and executes strategies for clinical and outcomes research studies that support regulatory approvals and strategic evidence initiatives. As part of the Clinical Affairs team, the manager works with stakeholders to design protocols and conduct pre-market or post-market clinical studies, with minimal supervision. The role collaborates with clinical research associates, clinical trial assistants, data management, and biostatisticians to carry out studies, interpret results, prepare clinical study reports, and support scientific publications. The manager leads studies through site selection, start-up, enrollment, follow-up, and closeout, providing direction to monitors and overseeing study compliance. Responsibilities also include developing study documents, coordinating regulatory and ethics submissions, monitoring sites, supporting audits and inspections, managing vendors, budgets, payments, and timelines, and communicating with investigators and study teams. The role also contributes to literature review, evidence strategy, regulatory submissions, and continuous improvement of Clinical Operations procedures. Travel of 25–40% or as business needs require is expected.

Requirements

Experience implementing, supporting, and managing medical device trials.
Significant knowledge of clinical and/or outcomes research study design.
Experience developing protocols and informed consent forms and writing clinical sections for regulatory submissions.
Experience conducting literature searches, reviews, and appraisals of scientific data.
Ability to interact effectively with physicians and other professionals inside and outside the company.
Knowledge of ICH/GCP and other applicable regulations, and fundamental knowledge of clinical research and monitoring requirements.
Experience negotiating clinical research contracts and budgets.
Ability to work effectively on cross-functional teams and manage multiple projects or shifting priorities.
Ability to travel 25–40% or as required by business needs.
Strong communication, presentation, and relationship skills, with attention to detail and organization.
Ability to learn quickly, adapt to changing requirements, and independently learn about relevant surgical specialties.
Ability to lead project teams consisting of CRAs and CTAs and provide management with relevant study updates.
Strong work ethic and problem-solving mindset, including the ability to meet tight timelines or manage multiple projects.
Minimum advanced degree in a scientific or bioengineering field (M.S., Ph.D., or M.D.) and at least 5 years of clinical research experience; alternatively, a bachelor's degree in a scientific or bioengineering field and at least 8 years of clinical research experience; or at least 10 years of clinical research experience with relevant training.

Nice To Haves

Experience working in a hospital environment and with nurses and surgeons.
Knowledge of statistics, statistical methods, and experimental design.

Responsibilities

Lead assigned clinical research activities and collaborate with stakeholders, investigators, and key opinion leaders on study concepts, designs, protocols, and initiatives.
Plan and execute clinical studies, including site selection, recruitment projections, study-document preparation, and IRB/EC submissions.
Conduct studies autonomously on schedule and within budget while maintaining quality and compliance.
Perform site qualification, initiation, interim monitoring, and closeout visits, both onsite and remotely.
Monitor studies for regulatory and protocol compliance and data accuracy; perform source data verification in electronic data capture systems, case report forms, or data listings.
Liaise with sites and support internal audits and inspections, maintaining sponsor audit readiness.
Negotiate vendor and site contracts and budgets in partnership with legal and management teams.
Track study progress and provide regular status reports.
Work with biostatisticians to analyze, interpret, and synthesize data; develop study reports and support scientific publications.
Track and process site payments and support study financial tracking.
Organize and lead study meetings and other study activities.
Mentor junior clinical study managers and guide CRAs and CTAs on monitoring and study needs.
Follow corporate SOPs and applicable regulatory requirements, including GCP and U.S. and non-U.S. guidelines.
Search, review, and critically appraise scientific literature; write clinical summaries to inform research and clinical strategies.
Review and revise Clinical Operations SOPs to support continuous process improvement.
For post-market research, partner with commercial groups to understand market trends and support business goals through Clinical Affairs activities.
Provide scientific expertise to Health Economics and Outcomes Research, including identifying diagnosis or reimbursement codes and selecting clinical outcomes.
Work with investigators to prepare manuscripts, abstracts, slide presentations, and posters for scientific meetings and publications.
Support regulatory submissions and approvals for pre-market studies and 510(k) submissions, including responses to regulatory questions about study design and results.