Intuitive · 2 hours ago
Senior Project Manager - Clinical
Sunnyvale, CA
Full-time
Onsite
Senior Level
$167K/yr - $241K/yr
5+ years expIntuitive is a global leader in robotic-assisted surgery and minimally invasive care. The Senior Project Manager, Clinical Workstream, will guide the planning and execution of clinical studies while providing strategic leadership and ensuring successful delivery of clinical objectives for innovative medical devices.
Health CareManufacturingMedical Device
Responsibilities
Lead the planning, initiation, and management of clinical workstream activities across pre-clinical, early feasibility, and pivotal study phases, ensuring alignment with program milestones and regulatory expectations
Develop and execute comprehensive project plans that reflect the Future Forward initiative’s strategic objectives, integrating timelines, resource allocation, and deliverable tracking for all clinical and pre-clinical activities
Coordinate with cross-functional teams including R&D, regulatory, clinical affairs, clinical development engineering, quality, and operations to ensure seamless integration of clinical deliverables within the product lifecycle
Partner with clinical development engineers to define experimental designs, establish study requirements, and provide technical support for pre-clinical studies, ensuring robust data generation and protocol compliance in both GLP and non-GLP settings
Oversee the preparation, submission, and maintenance of regulatory documents and study protocols in compliance with applicable standards and regulations (e.g., EC, IDE submissions) and ensure that pre-clinical documentation meets both internal and external audit requirements
Manage logistics for product availability in pre-clinical and clinical studies, including coordinating shipments, tracking inventory, and ensuring that devices and ancillary materials are delivered on time to appropriate sites
Implement and monitor procedures for product return following study completion, ensuring proper reconciliation, documentation, and disposition in accordance with quality and regulatory guidelines
Support the clinical affairs team by creating and maintaining tools to monitor study progress, proactively identify risks, and implement mitigation strategies to ensure project timelines and budgets are met
Facilitate regular clinical domain meetings, providing clear status updates to the program core team, capturing action items, and communicating decisions to relevant stakeholders
Coordinate with the clinical development team to manage interactions with internal and external laboratories, including scheduling, documentation transfer, and issue resolution, while fostering engagement with key opinion leaders (KOLs) to inform study design, execution, and data interpretation
Ensure high-quality documentation, reporting, and data integrity across all clinical and pre-clinical activities, supporting audit readiness and inspection activities for clinical trials as needed
Contribute to the continuous improvement of clinical project management processes and best practices, with a focus on enhancing cross-functional collaboration and operational efficiency within the clinical development framework
Qualification
Required
Bachelor's degree in Life Sciences, Engineering, or a related field; advanced degree (MS, PhD, or equivalent) preferred
Minimum of 5 years' experience in clinical project management, with at least 3 years focused on medical device development
Demonstrated experience managing pre-clinical, early feasibility, and pivotal clinical studies
In-depth knowledge of regulatory requirements governing medical device clinical trials (FDA, ISO 14155 (GCP), etc.)
Advanced organizational, planning, and prioritization skills; proficiency with project management tools and methodologies
Strong understanding of clinical research regulations and standards applicable to medical devices
Preferred
Proven track record of successful cross-functional project leadership in a regulated environment
Ability to inspire, influence, and drive teams toward common goals
Excellent written and verbal communication skills; adept at presenting complex information to diverse audiences
Proactive in identifying issues and developing effective solutions
Experience working with multidisciplinary teams and external partners
Commitment to accuracy and quality in all deliverables
Benefits
Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity.
Company
Intuitive
Intuitive designs and manufactures robotic-assisted surgical systems.
10001+ employees
H1B Sponsorship
Intuitive has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (339)
2024 (238)
2023 (181)
2022 (285)
2021 (145)
2020 (138)
Funding
Current Stage
Public CompanyTotal Funding
$5MKey Investors
St. Cloud Capital
2003-04-30Post Ipo Equity
2000-06-23IPO
1996-01-01Seed· $5M
Leadership Team
Craig Child
Sr. Vice President, Human Resources
Gillian Duncan
Senior Vice President, Professional Education & Program Services - Worldwide
Recent News
2025-12-11
2025-11-14
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