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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.

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Introduction

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Bonus

Homeoffice

Employee mobile phone

Flexible working hours

Laptop

Initial and continuing education

Canteen

Good transport connection

Employee events

Meal allowance

Company doctor

Parking spot

Healthmeasures

Employee discount

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