Description
We are looking for a
Clinical Study Manager (m/f)
Reference: -en
Start: asap
Duration: 3 MM++
Place: in Central Switzerland/the Swiss Plateau region
Branch: Herstellung von orthopädischen und prothetischen Erzeugnissen
Your tasks:
- Conduct clinical studies to support regulatory submissions
- Assist in the preparation of clinical study reports, regulatory documents and submissions
- Monitor and assist in monitoring activities to ensure compliance with study protocols, regulatory requirements and procedures
- Organise and lead internal and external meetings with associated communications and materials
Your qualifications
- Bachelor degree in life sciences or related field
- CCRP or CCRA certification desired
- Experience in the medical device or pharmaceutical industry in a clinical research setting
- Experience with Clinical Trial Management systems, Trial Master File systems, and electronic data capture
- Advanced knowledge of industry standards and best practices in clinical data management and regulations (US FDA, ISO, ICH)
- Study/project management skills
- Fluency in English, German is of advantage
Skills:
- Clinical project manager