Salary: Highly Competitive
In this role of Clinical Project Manager you will be responsible for oversight Clinical Projects.
Company: This Biotech are making progress in the field of Cardiology.
- Manage and provide accountability for day-to-day operations of the projects according to ICH/GCP and all other applicable laws, rules and regulations
- Management of external CROs
- Provide cross-functional oversight of internal project team members
- Submissions to FDA and EMA bodies
- Review and provide input for study protocol
- Support clinical operations process initiatives and SOP development activities
- Ideally MSc educated in a Life Science/ Science discipline. University level education will also be considered
- Working knowledge of EMA, FDA and GCP/ ICH regulations, laws and guidelines
- Familiar with organizing studies, approval of such studies and communicating with drug authorities
- No strict therapy area requirement: Cardiology would be a plus
- 3 - 5 years clinical trial experience within a CRO or pharmaceutical
- Business proficient in German, both written and spoken. Any other languages are desirable