The Phase of Clinical Trials plays a key role in the early life cycle of a medicinal product. Now it will be decided, whether a promising new molecule designed in a lab also provides safety and efficacy in humans. As far as new medicinal entities are concerned, now it is time to organize a huge Clinical Trial program, requiring quite often more qualified personnel for a certain timeframe. My expertise in Clinical Research – Project management is based on the following experience:
1) For about 2 years I have been the project leader for international multicenter Clinical Trials (phase II-III) in the indication of antiinfectives (about 40 sites in 5 EU- countries). This task included not only operational responsibilities such as investigator meetings, study initiation, on site monitoring or close out: Moreover I have been involved in the preparation of the statistical analysis plan and the data evaluation specifications based on it, I have been supervising the activities for Data Base Locks according to timelines. I have developed a Data Query Tracking System and I have written a Final Study Report.
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Hintergrundfoto: (c) Rainer Sturm / pixelio.de