Senior Clinical Study Manager

Intuitive

Sr. Clinical Study Manager developing and executing strategies for clinical studies at Intuitive, a leader in robotic-assisted surgery.

Posted 6/13/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $151,700 - $218,300 per yearWebsite

ATS Keywords

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Hard Skills

clinical researchclinical protocol developmentoutcomes research study designsource data verificationregulatory submission writingliterature searchclinical trial managementmedical device trialsGood Clinical Practice (GCP)clinical research contracts negotiation

Soft Skills

leadershipcommunicationpresentation skillsattention to detailorganizationinterpersonal skillscross-functional teamworkself-starter attitudeability to manage multiple projectsadaptability

Tools & Technologies

EDC systemcase report form

Industry Keywords

clinical trialsICH/GCPscientific data appraisalinvestigator communicationstudy team collaborationregulatory approvalsclinical study executionsite selectionenrollmentfollow-up

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Develop and execute strategies for clinical and outcomes research studies to help regulatory approvals and key strategic evidence initiatives.
Design and develop clinical protocols and execute clinical studies with minimal supervision.
Work closely with clinical research associates, clinical trial assistants, and data management for the conduct and execution of studies.
Drive the progress of the trial during site selection, site start-up and through 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.
Complete source data verification of clinical study data entered in EDC system or on case report form.

Requirements

What you’ll need

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”)

Benefits

Comp & perks

Health insurance
Flexible working hours
Professional development opportunities