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phenox rekrutiert für Positionen:
Project Manager
Verantwortlichkeiten
- Lead the end-to-end management of clinical studies for Class III medical devices, from feasibility assessment through study close-out
- Develop, maintain, and track clinical project plans, timelines, budgets, and risk management strategies
- Ensure all clinical studies are conducted in compliance with GCP , EU MDR, and applicable local regulatory requirements
- Oversee safety reporting activities, management of protocol deviations, and ensure inspection readiness
- Coordinate and collaborate with cross-functional teams, including Data Management, Clinical Research Associates , and other relevant internal stakeholders
- Monitor overall study progress, patient enrollment, data quality, and achievement of key milestones
- Identify, assess, and proactively mitigate study-related risks and issues; escalate critical topics as appropriate
- Provide regular written and verbal project updates to line management and ensure effective communication within the study team
Anforderung
- Bachelor's degree in Life Sciences, Engineering, Nursing, or a related discipline; Master's degree preferred
- Minimum of 5 years of hands-on experience in clinical project management
- Proven experience managing global and/or multi-center clinical studies
- Demonstrated experience working with Contract Research Organizations and external vendors
- Strong background in clinical development for implantable or other high-risk medical devices preferred
- In-depth knowledge of EU MDR clinical requirements and ISO 14155
- Familiarity with FDA clinical and regulatory requirements is a strong plus
- Experience working in highly regulated clinical environments with a strong focus on compliance and quality