• Lead integrated clinical project planning and governance for clinical investigations
• Define project structures, meeting cadences, reporting frameworks, and escalation pathways
• Drive cross-functional coordination across Clinical, RA, QA, Data, Safety, and external partners
• Develop and maintain project plans, timelines, milestones, budgets, and resource assumptions
• Track project progress and implement mitigation strategies for deviations
• Manage vendor performance, deliverables, timelines, and budgets
• Own project risk, issue, and decision logs; drive resolution and escalation where needed
• Prepare project status reports, dashboards, and leadership updates
• Ensure documentation, traceability, and inspection readiness of project activities
• Support submissions, audits, inspections, and major cross-functional decision-making processes

• Minimum 5 years of experience in clinical research or clinical project management
• Proven experience managing timelines, budgets, and vendor relationships
• Experience in medical device clinical investigations (Class III/high-risk devices preferred)
• Strong knowledge of ISO 14155, EU MDR 2017/745, and ICH-GCP principles
• Experience in cross-functional project leadership, stakeholder management, and reporting
• Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Medicine, Pharmacy, or a related field
• Fluency in English (written and spoken); additional languages are an advantage
• Project management certification (e.g., PMP, PRINCE2) is a plus
• Strong communication, organizational, and problem-solving skills

• An open corporate culture with the opportunity to contribute your own ideas
• Working independently in a collegial and committed team
• Modern working environment with good public transport connections (U4 - Heiligenstadt)
• Flexible working hours (flexitime/time-out days), bonus scheme, additional benefits and employee events
• Structured onboarding and support through a buddy system
• Due to legal requirements, we are obliged to disclose the collective agreement minimum salary, which is EUR 45.080,- gross per year, based on full-time employment. However, our actual remuneration packages are market-oriented and aligned with your qualifications and professional experience.

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