Experience

SAINTE CATHERINE, INSTITUT DU CANCER AVIGNON-PROVENCE

• France
• Wellness and Fitness Services
• 100 - 200 Employee

• Clinical Research Technician - Clinical Research Associate

  • Aug 2021 - Present

  Management of breast cancer clinical trials. Management of breast cancer clinical trials.



Alispharm by CBTW

• France
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Clinical Project Manager consultant in Medical Devices

  • May 2019 - Jan 2020

  Consultant as Clinical Project Manager in the Clinical Affairs Dept of Wright Medical, an orthopedics company based in Grenoble specialized in upper limbs prosthesis. Handling of several European PMCF studies on class II and III shoulder and elbow implants in partnership with internal stakeholders as well as external ones in Europe and US. - PMCF studies management - Good Clinical Practice compliance (ICH E6, ISO 14155) - Regulatory watch (EU MDR 2017/745) - Reflection on study feasibility - Conception, writing and review of studies documents and tools (Protocol, ICF, CRF/eCRF, TMF, ISF) - Study submission to Ethics Committees - Internal reporting (US and OUS Clinical team) - Coordination with US and OUS Clinical, Legal, Marketing, Compliance or R&D Department - Coordination with European investigators, CROs and service providers - Investigators’ contracts and fees handling - CRO supervision and invoices follow-up - Quarterly and annually budget planning (AOP, LBE) - Site Initiation, Monitoring and Close-Out Visits Show less



GROUPE AGIR à dom

• France
• Home Health Care Services
• 100 - 200 Employee

• Clinical Research Associate - Project Manager

  • Apr 2013 - Dec 2018

  Management of fifteen clinical trials in pulmonology field in AGIR à dom-Icadom's R&D team. PROJECT MANAGEMENT: - Good Clinical Pratice compliance - Regulatory watch - Study submission to Ethics Committees and Competent Authorities - Training of CRA trainees - Coordination with collaborators CLINICAL RESEARCH ASSOCIATE: - Conception, writing and review of studies documents and tools (Protocol, ICF, CRF/eCRF, TMF, ISF) - Studies operational follow-up (visits at home, logistic) - Oxymetries and sleep recordings - Data collection and data management - Vigilance - Use of study-specific devices and softwares (Nox A1/Noxturnal, GT3X/Actigraph, EDFbrowser, FileZilla) Show less



CHU Grenoble Alpes

• France
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Research Associate - Project Manager

  • Sep 2012 - Dec 2018

  SOON cohort (obese patients in bariatric surgery requests suffering from sleep apnea). - Follow-up of more than 700 subjects for several years - Blood sample handling - Good Clinical Pratice compliance - Study submission to Ethics Committees and Competent Authorities - Conception, writing and review of studies documents and tools (Protocol, ICF, CRF/eCRF, ISF) - Oxymetries and sleep recordings - Data collection and data management - Vigilance - Regulatory watch SOON cohort (obese patients in bariatric surgery requests suffering from sleep apnea). - Follow-up of more than 700 subjects for several years - Blood sample handling - Good Clinical Pratice compliance - Study submission to Ethics Committees and Competent Authorities - Conception, writing and review of studies documents and tools (Protocol, ICF, CRF/eCRF, ISF) - Oxymetries and sleep recordings - Data collection and data management - Vigilance - Regulatory watch



CHU Grenoble Alpes

• France
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Research Associate trainee

  • Jan 2012 - Jun 2012

  Master internship from April, 9th 2012 to September, 9th 2012 in Pneumology ward. - Subjects Follow-up at the hospital - ICF collection - Paramedical examinations - Data collection - CRF filling - Study submission file to the health authorities (Innovarc (DGOS website)) Master internship from April, 9th 2012 to September, 9th 2012 in Pneumology ward. - Subjects Follow-up at the hospital - ICF collection - Paramedical examinations - Data collection - CRF filling - Study submission file to the health authorities (Innovarc (DGOS website))