Clinical Research Manager (m/w) - Fixed Term Contract

SANDOZ
Division SANDOZ
Geschäftseinheit Product Dev SZ
Standort Holzkirchen (near Munich)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Temporary
StellenID 245072BR


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

We develop breakthrough treatments and find new ways to deliver them to as many people as possible to improve and extend peoples’ lives. We do this, by supporting and promoting the knowledge and strengths of our employees and specifically use them to deepen our understanding of our patients and customers. Motivating conditions and an attractive salary are also part of our working environment, as well as our company culture, which is based on collaboration, curiosity, enthusiasm, courage and integrity.
Novartis stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.



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