Intuitive
Healthcare
Sr.ProjectManager,ClinicalAffairs
“Sr. Project Manager, Clinical Affairs at Intuitive. Skills: Clinical Project Management, Medical Device Development, Cross-functional Leadership, Regulatory Compliance. Lead project planning for Clinical Affairs activities. Develop and maintain integrated project plans”
What You'll Achieve.
Ensure Clinical Affairs deliverables are completed successfully and on time; Translate Clinical Affairs objectives into actionable plans; Achieve milestones on time and within scope; Improve visibility, planning, and execution across the function
Industry & Context.
Troubleshooting execution challenges; Proactive in identifying issues and developing effective solutions
Occasional travel may be required, Proof of vaccination against certain diseases including COVID-19 may be required, May be subject to U.S. export controls, Consideration for arrest and conviction records
What They're Looking For.
Must Have
Bachelor’s degree in Life Sciences, Engineering, or a related field, Minimum of 5 years’ experience in clinical project management, At least 3 years focused on medical device development, Experience acting as a liaison between clinical and technical/project management teams, Knowledgeable with all stages of clinical studies, Knowledgeable with design control process, Knowledgeable with product development including idea generation, concept development and testing, design, implementation, validation and transfer, Advanced organizational, planning, and prioritization proficiency with project management tools, Understanding of clinical research regulations and standards applicable to medical devices, Familiarity with global regulatory requirements (e.g., FDA, EU MDR, ISO 14155, ICH GCP)
Nice to Have
Certification in project management (PMP), 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 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
What You'll Do.
Lead project planning for Clinical Affairs activities
Develop and maintain integrated project plans
Partner with cross-functional teams
Track progress against milestones
Facilitate routine cross-functional meetings
Coordinate activities within clinical affairs
Create and maintain tracking tools
Support budget and timeline adherence
Develop and deliver clear communications
Prepare executive-ready status materials
Serve as primary point of contact
Facilitate governance forums
Manage escalation pathways
Maintain high-quality project documentation
Identify execution risks and issues
Promote consistency across multiple clinical projects
Drive continuous improvement of project management processes
How You'll Work.
Team & Collaboration
Partner with key functions and business units; Cross-functional coordination; Collaboration with R&D, Regulatory, Business Units, Clinical Development Engineering, Quality, and PMO; Collaboration with subfunctions such as clinical operation, Clinical Data Management, Biostatistics, and Medical Sciences; Collaboration with stakeholders; Cross-functional working groups; Working with multidisciplinary teams and external partners
Communication Scope
Excellent written and verbal communication; Adept at presenting complex information to diverse audiences; Audience-appropriate communications
Process & Methodology
Project Planning, Oversight, Integrated project plans, Scope definition, Timeline management, Dependency management, Resourcing, Deliverables, Milestone tracking, Metric reporting, Portfolio status summaries, Risk management, Issue management, Change control, Governance forums, Escalation pathways, Project documentation, Continuous improvement
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