2013 - maintenantGeneral Activities:
-Good relationship with KOLs (Diabetology, Oncology, Psychiatry, Nephrology, Urology, Pediatrics).
-Conduct of feasibility studies on the national territory and Maghreb area.
-Coordination and contact the sellers (carriers, translators, medical analysis laboratory).
Project Management / Regulatory:
-Coordination between sponsors (CRO and pharmaceutical companies) and ARIANNE for the implementation of clinical trials.
-Reviewing documents/Translations.
-Preparing and reviewing Trial Master Files (TMF / eTMF).
-Preparing the Monitoring plan.
-Preparing and reviewing the submission folders (Paper and electronic files) for the regulatory authorities (Ethics committees, and Ministry of health)
-Applying the national and international regulation (ICH, GCP) of the clinical trials.
-Ensuring the regulatory vigilance of the clinical trials (national and international).
-Preparation of Audit.
-Training and support of new CRAs.
Pharmacovigilance:
-Collecting and managing safety data
-Editing pharmacovigilance reports
Sanofi-Aventis Algérie
- Attaché de recherche clinique
2010 - 2013-Implementation of the clinical trial (preselection of sites, conducting feasibility studies)
-Preparation of initiation meetings.
-Monitoring visits (pre-initiation, routine visit, and close-out visit) in accordance with GCP and SOPs.
-Review and verify CRF and other clinical data for completeness and accuracy with the source documents.
-Anticipate problems, the implementation of remedial actions, preventive and corrective.
-Report adverse events (AEs), serious adverse events (SAEs).
-Management of investigators payments.
Faculté de médecine d'Alger
- Enseignent vacataire, chargé de travaux dirigés
