Paris
Clinical Trial set-up, management and conducting of all types of global studies (Phase I to Phase IV, standard or non-standard project, collaborative, muti country) in accordance with international standards (ICH GCP, EU Directives and local regulations) in European countries
Coordinating and management of registry studies (ICH GCP, FDA requirements and local regulations) in USA, Latin America and Korean countries
I have started in clinical research on march 2004 as a CRA, then, as lead CRA, evolving to project manager position.
Good knowledge of GMP gained in previous pharmacist position in a manufacturing division of a pharmaceutical company
During the 8 years’ experience in pharmaceutical research and development, I have developed the following skills:
• Good knowledge and understanding of global study management roles and activities
• Good knowledge ICH-GCP guidelines, FDA regulation and applicable regulations
• Drug development process in both pharmaceutical companies and CRO
• Experienced with development of prospective site –selection criteria
• Experienced in interactions with outside vendors.e.g., CROs and contract labs
• Ongoing management of CRAs, Sites and , vendors, local staff and affiliates
• Well-developed interpersonal communication skills
• Line management skills
• Problem solving skills
• Ability to work effectively both as a member of a multidisciplinary team and independently
Further monitoring experience in France included 2 years as a CRA in Maghreb countries
Mes compétences :
Cardiology
Diabetes
Endocrinology
Oncology
Radiology
