Strategic and structured professional with over 15 years of experience in Clinical & Scientific Affairs
Extensive experience in the planning and implementation of clinical studies in the MedTech field
Expertise in various indications e.g. orthopedics or oncology
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Overview
- Availability
- Asap, 5 days/week, on-site & remote
- Qualification
- Dr. rer. nat. in Chemistry
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Neurology, Clinical Affairs, Strategic Clinical Research, ISO14155, Clinical Evaluations, PMCF, Evidence-based medicine, Medical Writing, Clinical Studies, Medical Device, Clinical Projekt Management
Key-Facts
Extract from previous activities
Medical Device Company, Germany
Clinical Research Manager Europe
Oversaw strategic clinical research across multiple EU countries for devices used in fluorescence-guided surgery, partially applied in neurosurgical settings
Development of relevant Standard Operating Procedures (SOP)
Clinical Operations (ISO 14155), Clinical Evaluation (EU-MDR)
Support MedEd and Sales teams by providing comprehensive evidence reports
Medical Device Company, Switzerland
Clinical Expert MedTech
Responsible for the design, coordination and monitoring of clinical studies to assess the safety and efficacy of new MedTech products
Strong exposure to neurology-relevant devices, such as surgical tools and implants impacting peripheral or central nervous systems
Conduct post-market clinical surveillance studies to monitor the long-term safety and performance of the products
Medical Device Company, Germany
Clinical Affairs Manager
Led a shared service clinical research team, managing studies across divisions
Supported various product lines, including devices with neurological and orthopedic interfaces
Collaborated with internal CRO and multiple functional stakeholders
Supporting multiple intra-company divisions – CRO within the company