Experience

MaaT Pharma

• France
• Biotechnology Research
• 1 - 100 Employee

• Clinical Trial Lead

  • Nov 2022 - Present



bioMérieux

• France
• Biotechnology Research
• 700 & Above Employee

• Global Medical Coordinator (Clinical Trial Manager )

  • Nov 2020 - May 2022

  Peri & Post Launch studies in ImmunoDiagnostics within Medical Affairs department. Phase 4 study of Biomarker in Sepsis Subjects at Risk of Developing Acute Kidney Injury. Collaborate with the Project Lead for: • CRO oversight for regulatory submission, sites activation, monitoring, site budget & contract. • Protocol and ICF development, selection of countries & investigators, • Activities related to data generation including eCRF development, • Review of regulatory documents (DSURS, CSR, regulatory responses), Primary contact for safety management. Development and implementation of internal pharmacovigilance process. In charge of the Data Protection Impact Assessment (GDPR). Manage Investigator Sponsor Studies.



bioMérieux

• France
• Biotechnology Research
• 700 & Above Employee

• Clinical Research Compliance Manager

  • Sep 2019 - Jun 2020

  In-Vitro Diagnostics studies (performance studies, sample collection, interventional studies, SARS-CoV-2 serology test study: - Provide clinical expertise to Clinical Affairs, R&D, Medical Affairs, Biobank departments having to manage clinical trials, - Ensure regulatory compliance: protocol and ICFs validation about bioethics consideration, data protection, - Support Biobanking department for submitting collection of biological samples to CODECOH, - Provide guidelines, tools and templates, dedicated watch and trainings, - Manage a team with 2 persons.



Excelya

• France
• Pharmaceutical Manufacturing
• 400 - 500 Employee

• Pharmacovigilance Project Management

  • Jan 2017 - Mar 2019



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Pharmacovigilance Audit & Inspection Readiness Manager

  • Jan 2017 - Dec 2018

  Consultant for EXCELYA Coordinate and prepare GPV Audit/Inspection readiness activities including PAI, GMP and GCP inspection in Europe, US, China, Australia. Provide support for selected Global Quality Audits impacting global PV processes or Business Partners Serve as the point of contact for audit/inspection activities interfacing and communicating with regulatory authority representatives Propose and monitor the implementation of corrective and preventive actions (CAPA). Consultant for EXCELYA Coordinate and prepare GPV Audit/Inspection readiness activities including PAI, GMP and GCP inspection in Europe, US, China, Australia. Provide support for selected Global Quality Audits impacting global PV processes or Business Partners Serve as the point of contact for audit/inspection activities interfacing and communicating with regulatory authority representatives Propose and monitor the implementation of corrective and preventive actions (CAPA).



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Program Manager

  • Apr 2016 - Aug 2016

  Vaccine studies - Lead the clinical team, report the study progress towards key milestones, - Planning and budget management - Collaborate to Audit/Inspection readiness: CAPA management Vaccine studies - Lead the clinical team, report the study progress towards key milestones, - Planning and budget management - Collaborate to Audit/Inspection readiness: CAPA management



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Trial Manager

  • Apr 2015 - Dec 2015

  Phase III vaccine study for subjects at risk of Cl. difficile Infection - Feasibility study and start-up activities: regulatory submissions in Romania, Czech Rep. and Slovakia, - CRO Management - Contribute to the sites selection Phase III vaccine study for subjects at risk of Cl. difficile Infection - Feasibility study and start-up activities: regulatory submissions in Romania, Czech Rep. and Slovakia, - CRO Management - Contribute to the sites selection



Hospices Civils de Lyon - HCL

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

• Clinical AQ & Pharmacovigilance Project Manager

  • Aug 2012 - Aug 2014

  FCRIN (French Clinical Research Infrastructure Network - INSERM): - Coordination of a national working group to elaborate quality standards regarding Vigilance and Study management, - Multicentric genetic rare disease study management: Systemic Lupus Erythematosus - Safety management, 200 open studies in the vigilance department (Drugs, MD, Other studies) FCRIN (French Clinical Research Infrastructure Network - INSERM): - Coordination of a national working group to elaborate quality standards regarding Vigilance and Study management, - Multicentric genetic rare disease study management: Systemic Lupus Erythematosus - Safety management, 200 open studies in the vigilance department (Drugs, MD, Other studies)



LYSARC

• France
• Research Services
• 1 - 100 Employee

• Pharmacovigilance Officer

  • Dec 2007 - Feb 2011

  LYSARC: The Lymphoma Academic Research Organization. Safety Management of 20 Phase I to III, national and international, Lymphoma studies. - Case processing, MedDRA coding, compliance review. - Prepared the aggregate safety reports (ASR, DSURs) and managed their submission to CA and IRB/EC. - Implemented a new safety data base (Safety Easy) including the testing and validation of the tool. - Wrote the internal SOPs and project specific procedures. LYSARC: The Lymphoma Academic Research Organization. Safety Management of 20 Phase I to III, national and international, Lymphoma studies. - Case processing, MedDRA coding, compliance review. - Prepared the aggregate safety reports (ASR, DSURs) and managed their submission to CA and IRB/EC. - Implemented a new safety data base (Safety Easy) including the testing and validation of the tool. - Wrote the internal SOPs and project specific procedures.



LYSARC

• France
• Research Services
• 1 - 100 Employee

• Clinical Data Manager & CRA

  • Feb 2003 - May 2006

  The Lymphoma Academic Research Organization / Phase II and III in Non-Hodgkinien Lymphoma studies - Support data management activities from the project team perspective - Prospecting vendors, test & roll-out a new data collection system (Clinsight / ENNOV) - Participate in data management plan design and data validation cleaning process (data flow processes, SOP writing), provide training and mentoring of new staff. - Coordinate the global monitoring activities (110 sites), manage CTA, maintain the TMF - site Initiation, monitoring to close-out visits of 10 sites



Mapi Group: Health Research & Commercialization

• France
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Project & Monitoring Assistant

  • Jan 2002 - Aug 2002

  Phase III, IV, Quality of life studies in diabetology and respiratory diseases

• Clinical Data Manager

  • Mar 2001 - Dec 2001

  Clinical Data Management / Phase III and IV studies (HIV, rheumatology).- Perform data entry and data review activities- Review CRF data through validation and QC checks- Generated queries and communicate with CRA's/study sites to obtain discrepancy resolutions