Clinical Research Manager (m/w)

SANDOZ
Division SANDOZ
Geschäftseinheit Product Dev SZ
Standort Holzkirchen (near Munich)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 245073BR


Stellenbeschreibung

- Development of study programs and study designs for complex global developments using scientific literature and relevant guidelines
- Preparation and / or review of study documents (e.g. protocol, subject information / consent forms, case report forms, statistical analysis plan, data management plan and study reports including data listings)
- Ensure proper study performance in accordance with GCP, national and international laws and internal GOPs and SOPs
- Coordination and control of the study timelines and ensure on-time study conduct
- Monitoring
- Evaluation, processing and presentation of study results
- Preparation of and participation in Scientific Advice Meetings with Heath Authorities
- Processing and Answering of deficiency letters by national and international Heath Authorities
- Budget planning and tracking for the supervised studies
- Cooperation in development project teams



Research & Development


Mindestanforderungen

- Bachelor’s Degree or MD/PHD in life science/healthcare required, pharmacy preferred
- Knowledge in pharmaceutical technology, pharmacokinetics, bio-analytics and clinical studies
- Experience in planning of study programs and study designs
- Experience in clinical operations, ideally in the field of phase I and phase III studies
- Careful, structured way of scientific thinking and working
- Strong communication and team skills, mental flexibility
- Very good MS Office knowledge
- Willingness for occasional business trips worldwide
- Language skills: English and German



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