We are looking for a Clinical Project Manager at OrphaCare to lead the planning, governance, and execution of clinical investigation projects for innovative medical devices. In this role, you will ensure integrated project delivery across cross-functional teams, driving timelines, budgets, and quality in line with regulatory requirements and company objectives. You will play a key role in translating clinical strategy into structured project execution while ensuring alignment across internal and external stakeholders.

What Your Day To Day Will Look Like

• 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

Your Qualifications And Experience

• 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

Our offer

• 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.