Grenoble
La recherche clinique est le milieu dans lequel je souhaite m'investir. Très motivée, en effet mon intérêt pour les sciences, la recherche et le relationnel y sont confortés. Par ailleurs rigueur et organisation font partie de mes compétences acquises à travers mes études et mon expérience professionnelle en dans le domaine du diagnostic du cancer.
Experience in conducting clinical research protocols according to Good Clinical Practice and national and international regulatory standards.
- Coordination on Clinical Trial in Oncology.
- Development of tools for patient support,
- Filling paper and electronic CRF,
- Carrying out of Activities related to Pharmacovigilance (SUSAR and SAE)
Quality control and Sterility Assurance management (isolator technology, aseptic conventional areas, blow fill sceal, rabs) for filling operations, Environmental monitoring strategy (grade ABCD), validation methods analysis
Fill & Finish operations for sterile products:
-Technology transfer, process validation, quality oversight
-Batch release, deviations, change controls and complaints management
-Problem solving, improvement process
-Competences development
-Qualification and Training processes for parenteral operations
-Risk analysis (HACCP · FMEA, ...) 5S, Housekeeping
-Support for Regulatory agencies inspection (ANSM, FDA)
Sterility Assurance management (isolator technology and aseptic conventional areas) for filling operations,
Environmental monitoring strategy (grade ABCD)
Project management :
-Registration new process, new products
-Qualification/ validation of new equipment
Team Management skills:
-led teams of up to 8 people, able to set organizational priorities, structure and resources
-influences others towards culture changes
Quality system ( global quality standard), internal and external audit experience
