Clinical Study Manager

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 Intuitives 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.

Remote Work :

No

Employment Type :

Full-time