Business Analyst (Clinical Trial)

Technical profile
- Strong business knowledge of clinical trial activities in the drug development processes, in particular Phase 1 trials and EDC systems
- In-depth knowledge of GCP and Part 11 legislation
- In-depth knowledge of validation methodologies (e.g. V-model), CSV (Computer System Validation)
- Strong project management skills
- Strong experience in vendor selection/package selection projects
- Experience with laboratory systems is a plus
- Experience with medical devices is a plus
- Experience with a requirements development methodology is a plus

Non-Technical profile
- Frequent international communication and team work through conference calls
- Strong tracking, coordination and project planning skills
- Ability to identify strategic process and/or application improvements
- Strong analytical and problem-solving skills
- Must be able to work on multiple simultaneous tasks with limited supervision
- Excellent interpersonal, communication and team collaboration skills
- Able to identify and incorporate procedures and internal guidelines

Methodology/Certification
- Master Degree or equivalent through experience.
- Advanced course work plus continued education in the listed technical disciplines is preferred
- Additional certification is a plus

Languages
- Excellent English spoken and written skills
- Dutch is required