Clinical Operations Manager (m/w/d)
Core
Managing and executing preclinical and clinical studies for medical device research, ensuring regulatory compliance and coordinating with vendors, study sites, and cross-functional teams.
Role type
Clinical Operations Manager
Builds
Clinical studies and regulatory submissions for medical device research
Domain
Medical devices / Clinical research
Required skills
Clinical study planning and execution, Vendor management (CROs, EDC), Regulatory compliance (MDR, GCP, ICH, FDA), Protocol and report writing, SOP development, Stakeholder coordination (physicians, study sites)
Preferred skills
Medical device study experience, English (fluent), German (fluent)
Technologies
MDR, GCP, ICH Guidelines, FDA Guidelines, ISO 14155
Responsibilities
Selecting and interacting with external vendors, Auditing and monitoring study centers and vendors, Leading study application submissions and agreement negotiations, Planning and conducting preclinical and clinical studies, Creating clinical study plans and reports, Ensuring regulatory quality requirements, Developing SOPs for clinical studies
Seniority
Mid-Senior, hands-on IC