Position: Senior Clinical Research Associate, Germany
Reports to: Project Management Clinical Research
The Client is a Germany based drug discovery firm developing certain compounds based upon and derived from its unique technology. The idea is to take innovative compounds to a certain stage in drug development and then share the results with a Pharma powerhouse. The Client is venture capital funded and therefore closely monitored by its investors. Possible rewards are high for every individual involved under the assumption that any one of its compounds passes registration.
Tasks:
- Support project management in laying out, organizing and monitoring international multicenter studies phases I-III.
- Participate in choosing CRO’s to work with and assist in coordinating all outside contract research
- Participate in choosing the centers and in monitoring those. Act as the scientific advisor to those.
- Assist in developing clinical development plans, study outlines and appropriate documentation
- Assist in planning and organization of investigator meetings
- Manage independently documentation and Trial Master Files
- Participate in filings
Qualification:
- Job experience with a CRO or within the pharmaceutical industry, preferably in drug development, e.g. with clinical studies phases I-III
- Thorough technical and scientific knowledge base; Science degree in Medicine, Biology, Chemistry
- Experience as Clinical Research Associate; with monitoring visits
- English fluent
Personality:
- Competent business behavior
- Independent working style
- Appreciate risk and chances associated with drug development