Clinical trials:
Coordination of Clinical Trial Material / Investigational Product supply to clinical sites according to Local legislation, Sponsor’s SOP and GCP / GDP / GMP
Coordination of Clinical Trial Material / Investigational Product use on clinical trial sites according to Local legislation, site’s SOP and GCP
Training of clinical / pharmacy personal on all aspects of drug accountability (including preparation of treatment)
Training of clinical personal on use of medical devices (when applicable)
Quality control:
QC laboratory team leadership
Organization of QC laboratory according to GMP
Planning and execution of Development and Validation of Analytical and Biochemical methods according to GMP, USP and PhEur
Auditing of QC laboratory methods and results
Preparation of regulatory required documents according to GMP (SOP, methods, reports…)
