Senior Clinical Study Manager

Intuitive

. Develop and execute strategies for clinical and outcomes research studies supporting regulatory approvals and strategic evidence initiatives .

Posted 10/21/2026full-timeRemote • Sunnyvale • California • United StatesSenior💰 $128,900 - $218,300 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical research study design, protocol development, and regulatory submissions, with a strong focus on compliance with Good Clinical Practice (GCP) and effective project management. Proven ability to collaborate with cross-functional teams and mentor junior staff while maintaining high attention to detail and organizational skills.

Highest-signal resume keywords

Clinical Research Study DesignProtocol DevelopmentGood Clinical Practice (GCP)Contract NegotiationData Analysis

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Protocol DevelopmentCase Report Form CreationSource Data VerificationStatistical Methods KnowledgeRegulatory Submission WritingClinical Trial Agreement PreparationIRB/EC Submission ManagementData ManagementClinical Outcomes ResearchLiterature Review and Appraisal

Soft Skills

Strong Communication SkillsPresentation SkillsRelational SkillsProblem-Solving MindsetAttention to Detail

Tools & Technologies

EDC SystemsClinical Trial Management Systems

Industry Keywords

Medical Device TrialsClinical ResearchRegulatory ComplianceCross-Functional Team CollaborationHospital Environment Experience

About the role

Key responsibilities & impact

Develop and execute strategies for clinical and outcomes research studies supporting regulatory approvals and strategic evidence initiatives
Design and develop clinical protocols and execute pre-market or post-market clinical studies with minimal supervision
Collaborate with CRAs, CTAs, data management, biostatisticians, investigators, KOLs and internal stakeholders
Plan and execute studies, including site selection, patient recruitment projections, site start-up, enrollment and follow-up
Create protocols, case report forms, informed consents, clinical trial agreements and study reports
Organize IRB/EC submissions and follow through to ensure study progress
Conduct site qualification, site initiation, interim monitoring and site close-out visits, both onsite and remotely
Monitor studies for regulatory and protocol compliance and data accuracy
Complete source data verification in EDC systems, case report forms or data listings
Support internal audits, inspections and sponsor audit readiness
Negotiate contracts and budgets with external vendors and sites in partnership with legal and management
Track study progress, provide status reports and manage site payments and study financial tracking
Work with biostatisticians on data analysis, interpretation and synthesis for clinical study reports and scientific publications
Organize study meetings and mentor junior clinical study managers
Provide guidance to CRAs and CTAs
Follow corporate SOPs, GCP and U.S. and international regulatory guidelines
Conduct literature searches, critically appraise scientific literature and write clinical summaries
Review and revise Clinical Operations SOPs for process improvement
Partner with commercial groups on post-market research and provide scientific expertise to Health Economics and Outcomes Research
Work with investigators to prepare manuscripts, abstracts, slide presentations and posters
Support regulatory submissions and approvals for pre-market studies and 510(k)s, including responses to regulatory questions

Requirements

What you’ll need

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 and writing clinical sections for regulatory submissions
Proven experience conducting literature searches, reviews and appraisal of scientific data
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
Ability to work effectively on cross-functional teams
Ability to travel 25–40% or based on business requirements
Ability to manage multiple projects and shifting priorities
Strong communication, presentation and relational skills with high attention to detail and organization
Ability to learn quickly, tailor to shifting requirements and self-educate on surgical specialties
Ability to drive project teams consisting of CRAs and CTAs
Solid work ethic and problem-solving mindset
Minimum advanced degree in a scientific/bioengineering field (M.S., Ph.D. or M.D.) with 5 years of clinical research experience, or bachelor's degree in a scientific/bioengineering field with 8 years of clinical research experience, or 10 years of clinical research experience with relevant training
Experience working in a hospital environment and with nurses and surgeons preferred
Knowledge of statistics, statistical methods and design of experiments highly preferred
Current proof of vaccination against certain diseases, including COVID-19, may be required
Candidates must comply with applicable U.S. export-control requirements where applicable

Benefits

Comp & perks

Remote work; employees come onsite when requested by the leader
Incentives
Benefits
Equity
Reasonable accommodations for qualified individuals with disabilities
Potential vaccination requirement, including COVID-19 vaccination, depending on the role or customer requirements