Clinical Project Manager(m/w/x)

## Job Description **Primary Function of Position:** Join our Clinical Affairs Department as a Clinical Project Manager, leading and supporting clinical studies across Europe. You'll oversee projects ranging from investigator-initiated to Intuitive-sponsored, ensuring compliance with GCP, ISO14155, and MDR regulations. Manage timelines, patient enrolment, and site performance while coordinating cross-functional contributions. Build relationships with investigators and represent Clinical Affairs in various forums. **Roles & Responsibilities****:** * Clinical Study Management (Sponsored, Collaborative and Investigator-Initiated) * Lead and support projects. * Plan and execute clinical studies in alignment with Intuitive’s internal procedures and global regulatory requirements. * Serve as the primary point of contact for study teams and investigators, supporting protocol development, feasibility, site start-up, contracting, and study conduct for assigned projects. * Coordinate cross-functional contributions (e.g. Medical Affairs, Legal, Compliance, Data Management) to ensure scientific and operational integrity. * Oversee project timelines, patient enrolment, site performance, safety reporting, and risk mitigation to ensure timely achievement of deliverables. * Ensure audit-ready documentation and maintain compliance with GCP, SOPs, and relevant global and regional regulatory standards. * Manage external vendors (e.g. CROs, academic collaborators) as needed, including contracts, performance oversight, and budget tracking. * Stakeholder Engagement and Communication * Build and maintain working relationships with external investigators, academic stakeholders, and research institutions, demonstrating confident stakeholder management and professional communication. * Represent Clinical Affairs in investigator meetings, advisory boards, safety committees, and steering groups as needed. * Scientific and Evidence Generation * Provide input into protocol design and endpoint selection; collaborate with statisticians and data teams to ensure methodological robustness. * Support the development and review of core study documents (e.g. protocols, CRFs, ICFs, study reports) and contribute to publication planning and manuscript development. * Site Monitoring and Data Quality * In partnership with the study team, implement site monitoring and data quality plans. * Provide onsite monitoring operational support as required. * Review and approve site monitoring visit reports; follow up to ensure clear, timely reporting and resolution of site issues. * Apply practices to promote data quality and compliance. ## Qualifications **Required Knowledge, Skills, and Experience****:** * *3*+ years experience in medical device clinical research. * Graduate qualification in Life Sciences, medicine, or medical sciences. A PhD qualification is an advantage. * Knowledge of applicable medical device regulations and guidelines including GCP, ISO-14155, MDR and Data protection rules across Europe. * Protocol and CRF development experience. * Strong numerical and literacy skills - ability to assess data and literature quickly. * Experience reviewing clinical data sets to evaluate data quality and address issues as needed. * Experience in soft-tissue surgery and/or robotic surgery. * Proven ability to manage Contract Research Organizations (CROs) or external clinical service providers. * Experience contributing to or authoring clinical research publications, either in an academic or industry-sponsored setting. * Demonstrated experience in collaborating with key accounts, medical societies, patient organizations, or clinical opinion leaders. * Experience in managing or supporting studies with a health economics or outcomes research focus. * Excellent communication and interpersonal skills with strong influencing abilities. * Ability to work independently and across teams whilst keeping open communication with key stakeholders. * Proficiency in English; a second European language (e.g. German, French) is a plus. **#LI-Hybrid** ## Additional Information Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.