Clinical Study Manager (m/w/d)

Primary Function of Position:
Join our Clinical Affairs Department as a Clinical Project Manager leading and supporting clinical studies across Europe. Youll 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 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 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 :

Wir schtzen jede Person in ihrer Individualitt unabhngig von Geschlecht ethnischer oder sozialer Herkunft Religion besonderen Bedrfnissen Alter oder sexueller Identitt. Diskriminierung hat bei uns keinen Platz.

Remote Work :

No

Employment Type :

Full-time