- Medical writing (e.g. clinical evaluation plan and report, clinical investigation plan and report, monitoring plan, statistical analysis plan, data management plan, scientific publications)- Competent authority and ethics committee submissions- Project and investigational site management of (inter)national clinical trials with medical devices- Providing support in the start-up, enrollment, follow-up and closure of clinical trial activities- Ensuring that the rights and well-being of subjects are protected and that the study data are accurate and verifiable from source documents- Ensuring that the milestones, timelines, budgets and quality of clinical trials are met as outlined in protocols, SOPs, ISO/GCP and the applicable regulatory requirements- Sponsor, investigator and vendor interactions

- Medical writing.- Investigator's Brochure (IB) and Investigational Medicinal Product Dossier (IMPD).- EMA Orphan Designation application.- Contribution to clinical trial start-up.- Design, planning and execution of preclinical research experiments (internal/external).- Data analysis, reporting and presentation (internal/external).- ATMP manufacturing performance and quality goals (GMP).- Aseptic manufacturing and process validations.- Train and supervise employees.- Contribution to QMS.

- Preclinical studies (proof of concept, in vitro, follow-up of toxicity and tumorigenicity studies)- ATMP development and manufacturing- Design, planning and execution of preclinical experiments (internal/external)- Data analysis, reporting and presentation (internal and external)

Keywords: neuroscience, rare diseases, metabolism, ataxia.Preclinical studies, design, planning and execution of research experiments, data analysis, reporting and presentation (internal and external), teaching, supervision of master students, ombudswoman.