Clinical Study Manager

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of Position

The purpose of this job function is to serve as a Clinical Project Manager (CPM) in the Clinical Affairs Department to support projects across Europe. This role has responsibility for the development, initiation, progress and conduct of clinical studies across a portfolio ranging from investigator initiated to Intuitive sponsored. This role will lead smaller, less complex projects; and will support or co-lead larger, more complex projects.

The candidate will ensure clinical trial conduct in compliance with applicable laws, regulations MDD/MDR, ISO14155, guidance Good Clinical Practices (GCP), and Intuitive Surgical SOPs.

Essential Job Duties

• Clinical Study Management (Sponsored, Collaborative and Investigator-Initiated)

• Lead smaller or less complex clinical projects; support larger or more complex 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 & 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 & 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.

• Process Improvement and Compliance

Participate in clinical team meetings and maintain full compliance with Intuitive Surgical policies and procedures.

Qualifications

Required Skills and Experience

• Experience working in the medical device industry in clinical affairs/research function with evidence of clinical project management responsibility for at least three years.
• 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.
• Excellent communication and interpersonal skills with strong influencing abilities.
• Ability to work independently and across teams whilst keeping open communication with key stakeholders.
• Ability to manage multiple clinical research projects.

Required Education and Training

• Graduate qualification in Life Sciences, medicine, or medical sciences. A PhD qualification is an advantage.
• Proficiency in English.

Working Conditions

• Ability to travel up to 25% throughout Europe.
• Comfortable in a hospital/surgical environment.

Preferred Skills and Experience

• 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.
• Previous experience as a Clinical Research Associate (CRA).
• Demonstrated experience in collaborating with key accounts, medical societies, patient organizations, or clinical opinion leaders.
• Proficiency in a second European language (e.g. German, French).
• Experience in managing or supporting studies with a health economics or outcomes research focus.

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.