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The Company: The recruiting Company is a major international actor in the field of medical device which mission is to permanently create value through new technologies and supports.
Since 2001, the Company is developing, a fruitful new business in Regenerative Medicine by means of internal R&D and in-licensing.
The Company has recently acquired worldwide rights on a biologic agent for wound healing, already marketed on one major territory, and intends to develop and file it in Europe. The first indication explored will be the “Diabetic Foot”.
Further development programs will cover other indications (ie. vascular ulcers).
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The Position: Reporting to the European Clinical Project Leader, his/her main responsibilities will be:
- To control all activities regarding the preparation, the monitoring and the completion of the Clinical Trials in local sites operated with the CRO, within forecasted timelines
- To review study documents (protocol, amendments) and writing the monitoring plan
- To control / audit all parties involved in the Clinical Program (CRO and local clinical centres), ensuring the study is performed according to quality standards (SOPs, GCPs, ICH guidelines).
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