Senior Clinical Study Manager

Job not on LinkedIn

🕒 January 6

🏄 California – Remote

🏄 California – Remote

💵 $147.6k - $212.4k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Intuitive

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1995

⚕️ Healthcare Insurance

Healthcare Insurance • Medical Devices

Intuitive is a company known for its innovative surgical technologies, including the da Vinci Surgical Systems which are used for minimally invasive procedures. With three decades of demonstrated performance, Intuitive focuses on advancing healthcare by providing structured and measurable technology training pathways for surgeons, physicians, and OR care teams. Their vision is to improve patient outcomes through less invasive surgical care. Intuitive also offers a visual media platform for collaboration and learning, known as the Da Vinci Hub, and the Simnow platform for surgical training. The company is involved in ongoing innovation to explore new possibilities in surgical care.

📋 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. • The candidate will be required to work closely with clinical research associates (CRAs), clinical trial assistants (CTAs) and data management for the conduct and execution of the study, as well as with biostatisticians to review and interpret results of clinical studies, develop clinical study reports, or help the development of clinical publications. • During trial execution, the CSM will drive the progress of the trial during site selection, site start-up and through enrollment and follow-up. • The CSM will clearly provide guidance to the monitors about monitoring needs, and oversee compliance work on the study. • The CSM will also take a leadership role in external communication with investigators and study teams.

🎯 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 is preferred, or a minimum of 10 years of experience in clinical research with relevant training. • 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 the 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, fundamental knowledge of clinical research and monitoring requirements • 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 as applicable to clinical projects (“Self-starter attitude”). • 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.

🏖️ Benefits

• Health insurance • Paid time off • Professional development opportunities