Clinical Study Manager (m/w/d)

Job title:

Clinical Study Manager (m/w/d)

Company

Intuitive Surgical

Job description

Company DescriptionAt 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 DescriptionPrimary 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.

QualificationsRequired 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-HybridAdditional InformationWir schätzen jede Person in ihrer Individualität – unabhängig von Geschlecht, ethnischer oder sozialer Herkunft, Religion, besonderen Bedürfnissen, Alter oder sexueller Identität. Diskriminierung hat bei uns keinen Platz.

Expected salary

Location

Freiburg, Baden-Württemberg

Job date

Wed, 20 Aug 2025 04:14:02 GMT

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