You are working in the Clinical Research & Development department which conducts firstinman clinical trials and Phase III proofofconcept studies for our new assets worldwide.
- As Clinical Trial Manager you are responsible for the planning execution and management of all aspects of clinical trials primarily in the field of cell and gene therapies.
- You ensure that all trials are conducted out in accordance with all relevant pharmaceutical regulations (e.g. GCP and applicable SOPs) quality budget and timelines.
- You develop effective relationships with internal and external stakeholders and work in regular and very close contact with colleagues from Quality Assurance Regulatory Affairs R&D Manufacturing Clinical Supply Chain Management study sites relevant third parties such as CROs laboratories and auditors as well as with regulatory authorities and ethic committees.
- Within the Clinical Clinical research team you work to continuously improve the required SOPs.
Qualifications :
- You have successfully completed your scientific degree (for example in chemistry biology pharmacy or medicine or similar); a PhD would be an advantage.
- You already have several years of professional experience in clinical research and in the management of (international) clinical trials according to GCP. Experience in clinical monitoring is an advantage.
- Ideally you have a solid background in immunology hematology oncology or autoimmune diseases and are strong interest in cell & gene therapies.
- You are a selfstarter proactive goaloriented and are an experienced project team leader. You are naturally communicative and you communicate confidently and appropriately in both German (B2) and English (C1).
- You are willing to undertake international travel (approx. 1020% of your time).
Remote Work :
No
Employment Type :
Fulltime