Nabil Mehdaoui

Management of clinical trial ensuring compliance with GCP, relevant SOP’s, and

regulatory requirements.

Acting as a primary liaison between the company and service provider such as the

central laboratory, elearning vendor… to ensure timely study launch, conduct, and

closeout according to the Customer’s and the Company’s contractual agreement.

Lead project team to ensure quality, timelines and budget management.

Coordinate activities and deliverables of all study conduct partners and proactively

identify and manage issues.

Accountable for maintenance of study information on a variety of databases and

systems.

Responsible for study management components of i

Montpellier-France- Aixial pour Sanofi

conduction, set-up clinical trials of Sanofi .managing access, supporting global study managers in cleaning CRF (patient data review and deviation review), archiving all relevant documentation in the Trial management file (TMF).

Management of the patient reimbursement and elearning platform vendor (service provider)

Conducted day to day execution of clinical trial research protocols (around 15 in a same period) including obtaining informed consent, completing study procedures and dispensing, accounting for study drug and documenting drug compliance.

Responsabilities included: Ensure acurate data recording and queries resolutions ; Acquainted in using electronic data capture tools such as Oracle, clinical RDC, Medidata RAVE ; Ensure timely processing, review and validation of clinical data ; communication with central clinical trial laboratories and sponsor, managing ethical approval for studies from initical study approval through study amendments, anual continuations, and finally termination.

Sample preparation after blood collection (centrifugation, aliqot, ESR…), storage, processing and shipping according to the flowcharts; ensure study timelines and resource meet the study expectations; documented and conducted appropriate correspondence regarding adverse events, including multiple severe adverse event