-
Charles River Laboratories
- Head of Necropsy & Histology Department & senior Manager - Toxicology general
SAINT-GERMAIN-SUR-L'ARBRES
2015 - maintenant
Major responsibilities:
Operational responsibilities for the development and management of the Necropsy & histology group at Charles River Lyon (37 collaborators with BSc levels) to focus the efforts towards improving productivity, quality of work and the welfare of animals
Ensuring that post-life part of studies are performed according to study plan requirements, adhere to departmental Standard Operating Procedures (SOP's), and comply with Good Laboratory Practice (GLP) and Ethical Guidances.
Providing the leadership of technical procedures conducted post-life, and ensuring that staff is adequately trained
Preparing and implementing new SOP's when needed.
Interacting with Study Directors, Pathologists, Clients and Executive Management for quality of work and the welfare of animals.
Assumes fiscal responsibilities for the department and assists in the production of departmental budgets.
Actively contributes to the selection and recruitment of staff, recommends career
Facilitates timely communication and cooperation between matrix team members. Establishes departmental standards for quality (technical and regulatory) and safety and enforces them through SOPs, policies, training, and interactions with personnel.
-
Charles River Laboratories
- Head of Necropsy & Histology Department & senior Manager - Toxicology general
SAINT-GERMAIN-SUR-L'ARBRES
2015 - maintenant
Major responsibilities:
Operational responsibilities for the development and management of the Necropsy & histology group at Charles River Lyon (37 collaborators with BSc levels) to focus the efforts towards improving productivity, quality of work and the welfare of animals
Ensuring that post-life part of studies are performed according to study plan requirements, adhere to departmental Standard Operating Procedures (SOP's), and comply with Good Laboratory Practice (GLP) and Ethical Guidances.
Providing the leadership of technical procedures conducted post-life, and ensuring that staff is adequately trained
Preparing and implementing new SOP's when needed.
Interacting with Study Directors, Pathologists, Clients and Executive Management for quality of work and the welfare of animals.
Assumes fiscal responsibilities for the department and assists in the production of departmental budgets.
Actively contributes to the selection and recruitment of staff, recommends career
Facilitates timely communication and cooperation between matrix team members. Establishes departmental standards for quality (technical and regulatory) and safety and enforces them through SOPs, policies, training, and interactions with personnel.
-
Charles River Laboratories
- Head of necropsy department
SAINT-GERMAIN-SUR-L'ARBRES
2015 - maintenant
Operational responsibility for the development and management of the Necropsy group at Charles River Lyon (10 collaborators with BSc levels) to focus the efforts towards improving productivity, quality of work and the welfare of animals
Ensuring that post-life part of studies are performed according to study plan requirements, adhere to departmental Standard Operating Procedures (SOP’s), and comply with Good Laboratory Practice (GLP) and Ethical Guidances.
Providing the leadership of technical procedures conducted post-life, and ensuring that staff is adequately trained
Preparing and implementing new SOP’s when needed.
Interacting with Study Directors, Pathologists, Clients and Executive Management for quality of work and the welfare of animals.
Assumes fiscal responsibilities for the department and assists in the production of departmental budgets.
Actively contributes to the selection and recruitment of staff, recommends career
Facilitates timely communication and cooperation between matrix team members. Establishes departmental standards for quality (technical and regulatory) and safety and enforces them through SOPs, policies, training, and interactions with personnel.
-
Charles River Laboratories
- Head of Necropsy & Histology Department & senior Manager - Toxicology general
SAINT-GERMAIN-SUR-L'ARBRES
2015 - maintenant
Major responsibilities:
Operational responsibilities for the development and management of the Necropsy & histology group at Charles River Lyon (37 collaborators with BSc levels) to focus the efforts towards improving productivity, quality of work and the welfare of animals
Ensuring that post-life part of studies are performed according to study plan requirements, adhere to departmental Standard Operating Procedures (SOP's), and comply with Good Laboratory Practice (GLP) and Ethical Guidances.
Providing the leadership of technical procedures conducted post-life, and ensuring that staff is adequately trained
Preparing and implementing new SOP's when needed.
Interacting with Study Directors, Pathologists, Clients and Executive Management for quality of work and the welfare of animals.
Assumes fiscal responsibilities for the department and assists in the production of departmental budgets.
Actively contributes to the selection and recruitment of staff, recommends career
Facilitates timely communication and cooperation between matrix team members. Establishes departmental standards for quality (technical and regulatory) and safety and enforces them through SOPs, policies, training, and interactions with personnel.
-
Sanofi Pasteur
- Clinical Supply Chain manager
Lyon
2013 - 2015
Ensuring products sourced/booked are validated;
Identifying any risks associated to the product demand;
Escalating and mitigating risks with support of Quality Assurance unit, as requested;
Ensuring the randomization list availability;
Preparing and chairing the kick off meeting including invitation to the key stakeholders (e.g. Clinical, Packaging Unit and other ad hoc stakeholders);
Developing the TASQ in collaboration with sponsor representatives (Clinical R&D, GMA, USMA);
Approving the Technical agreement for services and Quotation; archiving the TASQ once approved and initiating any update if needed;
Developing and approving the packaging Order in accordance with TASQ.
-
Sanofi Pasteur
- Clinical Supply Chain Manager
Lyon
2013 - 2015
Clinical Phase III and IV Pediatric: immunology, efficacy and safety study
Major responsibilities:
Ensuring products sourced/booked are validated;
Identifying any risks associated to the product demand;
Escalating and mitigating risks with support of Quality Assurance unit, as requested;
Ensuring the randomization list availability;
Preparing and chairing the kick off meeting including invitation to the key stakeholders (e.g. Clinical, Packaging Unit and other ad hoc stakeholders);
Developing the TASQ in collaboration with sponsor representatives (Clinical R&D, GMA, USMA);
Approving the Technical agreement for services and Quotation; archiving the TASQ once approved and initiating any update if needed;
Developing and approving the packaging Order in accordance with TASQ.
-
Sanofi Pasteur
- Clinical Supply Chain Manager
Lyon
2013 - 2015
Clinical Phase III and IV Pediatric: immunology, efficacy and safety study
Major responsibilities:
Ensuring products sourced/booked are validated;
Identifying any risks associated to the product demand;
Escalating and mitigating risks with support of Quality Assurance unit, as requested;
Ensuring the randomization list availability;
Preparing and chairing the kick off meeting including invitation to the key stakeholders (e.g. Clinical, Packaging Unit and other ad hoc stakeholders);
Developing the TASQ in collaboration with sponsor representatives (Clinical R&D, GMA, USMA);
Approving the Technical agreement for services and Quotation; archiving the TASQ once approved and initiating any update if needed;
Developing and approving the packaging Order in accordance with TASQ.
-
Sanofi Pasteur
- Clinical Supply Chain Manager
Lyon
2013 - 2015
Clinical Phase III and IV Pediatric: immunology, efficacy and safety study
Major responsibilities:
Ensuring products sourced/booked are validated;
Identifying any risks associated to the product demand;
Escalating and mitigating risks with support of Quality Assurance unit, as requested;
Ensuring the randomization list availability;
Preparing and chairing the kick off meeting including invitation to the key stakeholders (e.g. Clinical, Packaging Unit and other ad hoc stakeholders);
Developing the TASQ in collaboration with sponsor representatives (Clinical R&D, GMA, USMA);
Approving the Technical agreement for services and Quotation; archiving the TASQ once approved and initiating any update if needed;
Developing and approving the packaging Order in accordance with TASQ.
-
CH Le Vinatier - CPS Psy mobile
- Coordinateur de projet
2012 - 2013
Implementation and coordination of the epidemiological study of suicide prevention program in nursing homes under the direction of the Regional Health Agency (ARS)
Monitoring of selected sites; collection of raw data; choice of indicator for analysis; administrative and budgetary tasks; public tender offers
Presentation at the ARS throughout the project
-
ARS/CHU le Vinatier
- Clinical Research Associate
2012 - 2013
Epidemiology study in human psychiatry
Major responsibilities:
Implementation and coordination of the epidemiological study of suicide prevention program in nursing homes under the direction of the Regional Health Agency (ARS)
Monitoring of selected sites; collection of raw data; choice of indicator for analysis; administrative and budgetary tasks; public tender offers
Presentation at the ARS throughout the project.
-
ARS/CHU le Vinatier
- Clinical Research Associate
2012 - 2013
Epidemiology study in human psychiatry
Major responsibilities:
Implementation and coordination of the epidemiological study of suicide prevention program in nursing homes under the direction of the Regional Health Agency (ARS)
Monitoring of selected sites; collection of raw data; choice of indicator for analysis; administrative and budgetary tasks; public tender offers
Presentation at the ARS throughout the project.
-
ARS/CHU le Vinatier
- Clinical Research Associate
2012 - 2013
Epidemiology study in human psychiatry
Major responsibilities:
Implementation and coordination of the epidemiological study of suicide prevention program in nursing homes under the direction of the Regional Health Agency (ARS)
Monitoring of selected sites; collection of raw data; choice of indicator for analysis; administrative and budgetary tasks; public tender offers
Presentation at the ARS throughout the project.
-
MERIAL
- CRA Study Director
Lyon
2007 - 2012
Assist investigator and study director in the administration of GLP and GCP (station, mono-site and multisite) studies: clinical supplies inventory, data capture, data storage, study administration and status reports, protocols and reports, grants payments, contract and regulatory affair, generation of quality plans
Assist with monitoring and coordination studies : responsible for investigator selection and training, critical phases, clinical monitoring, study related correspondence, field trial notebook preparation, study set-up and termination, randomization and logistics, data management, monitoring visits and close-out visit, adverse event reporting
Responsible for quality control: check documents for accuracy, and compliance with procedure, coordinate and conduct as required in-life checks of investigators and data generation
Support activities directed from Harlow Clinical Unit
Management of technical team
Interaction and participation to meeting with project team
-
MERIAL
- CRA/Study Director
Lyon
2007 - 2012
MERIAL, - veterinary clinical trial
-------
Clinical phase II: toxicology, PKPD, efficacy and safety studies - National and International studies: 10 studies with 1 site: 40 patients by site (average)
Clinical phase III: Field trial, multisite studies - International studies: 4 studies with 15 sites/study
Major responsibilities:
Assist investigator and study director in the administration of GLP and GCP (station, mono-site and multisite) studies: clinical supplies inventory, data capture, data storage, study administration and status reports, protocols and reports, grants payments, contract and regulatory affair, generation of quality plans
Assist with monitoring and coordination studies : responsible for investigator selection and training, critical phases, clinical monitoring, study related correspondence, field trial notebook preparation, study set-up and termination, randomization and logistics, data management, monitoring visits and close-out visit, adverse event reporting
Responsible for quality control: check documents for accuracy, and compliance with procedure, coordinate and conduct as required in-life checks of investigators and data generation
Support activities directed from Harlow Clinical Unit
Management of technical team
Interaction and participation to meeting with project team
-
MERIAL
- CRA/Study Director
Lyon
2007 - 2012
MERIAL, - veterinary clinical trial
-------
Clinical phase II: toxicology, PKPD, efficacy and safety studies - National and International studies: 10 studies with 1 site: 40 patients by site (average)
Clinical phase III: Field trial, multisite studies - International studies: 4 studies with 15 sites/study
Major responsibilities:
Assist investigator and study director in the administration of GLP and GCP (station, mono-site and multisite) studies: clinical supplies inventory, data capture, data storage, study administration and status reports, protocols and reports, grants payments, contract and regulatory affair, generation of quality plans
Assist with monitoring and coordination studies : responsible for investigator selection and training, critical phases, clinical monitoring, study related correspondence, field trial notebook preparation, study set-up and termination, randomization and logistics, data management, monitoring visits and close-out visit, adverse event reporting
Responsible for quality control: check documents for accuracy, and compliance with procedure, coordinate and conduct as required in-life checks of investigators and data generation
Support activities directed from Harlow Clinical Unit
Management of technical team
Interaction and participation to meeting with project team
-
MERIAL
- CRA/Study Director
Lyon
2007 - 2012
MERIAL, - veterinary clinical trial
-------
Clinical phase II: toxicology, PKPD, efficacy and safety studies - National and International studies: 10 studies with 1 site: 40 patients by site (average)
Clinical phase III: Field trial, multisite studies - International studies: 4 studies with 15 sites/study
Major responsibilities:
Assist investigator and study director in the administration of GLP and GCP (station, mono-site and multisite) studies: clinical supplies inventory, data capture, data storage, study administration and status reports, protocols and reports, grants payments, contract and regulatory affair, generation of quality plans
Assist with monitoring and coordination studies : responsible for investigator selection and training, critical phases, clinical monitoring, study related correspondence, field trial notebook preparation, study set-up and termination, randomization and logistics, data management, monitoring visits and close-out visit, adverse event reporting
Responsible for quality control: check documents for accuracy, and compliance with procedure, coordinate and conduct as required in-life checks of investigators and data generation
Support activities directed from Harlow Clinical Unit
Management of technical team
Interaction and participation to meeting with project team
-
MERCK
- Biomedical Engineer - diabetology
Lyon
2006 - 2007
MERCK / CNRS (ANIMET), - renal physiopathology and metabolism
-------
Clinical phase II: pharmacology efficacy - optimal dose: 1 site: 40 patients
Major responsibilities:
Assist general practitioner for studies: responsible for development of a drug for diabetes (set-up experimentation and supervision study, training monitor, interaction with project team hierarchy, presentation of results and report, adverse event reporting)
Responsible for patients selection and training, for monitoring visits of CRF and notebook preparation
Support for analyse result by RMN and collaboration with Laboratory,
Interaction with other engineer and technician: management, Lab meeting, briefing, training, information
Responsible for the preparation of the biosafety ``Risk Assessment'' prior to the organisation of every study
Participation to meeting with project team
-
MERCK
- Biomedical Engineer
Lyon
2006 - 2007
Assist general practitioner for studies: responsible for development of a drug for diabetes (set-up experimentation and supervision study, training monitor, interaction with project team hierarchy, presentation of results and report, adverse event reporting)
Responsible for patients selection and training, for monitoring visits of CRF and notebook preparation
Support for analyse result by RMN and collaboration with Laboratory,
Interaction with other engineer and technician: management, Lab meeting, briefing, training, information
Responsible for the preparation of the biosafety “Risk Assessment” prior to the organisation of every study
Participation to meeting with project team
-
MERCK
- Biomedical Engineer - diabetology
Lyon
2006 - 2007
MERCK / CNRS (ANIMET), - renal physiopathology and metabolism
-------
Clinical phase II: pharmacology efficacy - optimal dose: 1 site: 40 patients
Major responsibilities:
Assist general practitioner for studies: responsible for development of a drug for diabetes (set-up experimentation and supervision study, training monitor, interaction with project team hierarchy, presentation of results and report, adverse event reporting)
Responsible for patients selection and training, for monitoring visits of CRF and notebook preparation
Support for analyse result by RMN and collaboration with Laboratory,
Interaction with other engineer and technician: management, Lab meeting, briefing, training, information
Responsible for the preparation of the biosafety ``Risk Assessment'' prior to the organisation of every study
Participation to meeting with project team
-
MERCK
- Biomedical Engineer - diabetology
Lyon
2006 - 2007
MERCK / CNRS (ANIMET), - renal physiopathology and metabolism
-------
Clinical phase II: pharmacology efficacy - optimal dose: 1 site: 40 patients
Major responsibilities:
Assist general practitioner for studies: responsible for development of a drug for diabetes (set-up experimentation and supervision study, training monitor, interaction with project team hierarchy, presentation of results and report, adverse event reporting)
Responsible for patients selection and training, for monitoring visits of CRF and notebook preparation
Support for analyse result by RMN and collaboration with Laboratory,
Interaction with other engineer and technician: management, Lab meeting, briefing, training, information
Responsible for the preparation of the biosafety ``Risk Assessment'' prior to the organisation of every study
Participation to meeting with project team
-
Center International de recherche sur le cancer
- Trainee
2005 - 2005
Responsible for the development of descending of mice transgenic,
Coordination of experimentation for amelioration of techniques to determine protein SER249 of gene TP53: drug molecule-test of the study of the cancer of the liver: pharmacokinetic, dose confirmation and efficacy, in-vitro test,
At the same time assist director study in the realization with this molecule for tolerance and optimal condition to prescription (notebook preparation, participation of briefing and meeting with project team, CRF capture, reporting of adverse event, report, ..)
-
Center of Nuclear Magnetic Resonance
- Various
2001 - 2004
* University Claude Bernard Lyon I
Senior technician: set up by practical jobs for the students of professional licences of Chemistry, Biochemistry
and Biology (Plant, biocell Biology, Microbiology, Genetics and Immunology, HPLC).
* Center of Nuclear Magnetic Resonance (RMN).
Senior technician: responsible of relations with the different laboratories of chemical, medical and pharmaceutical research. Analysis of samples by nuclear magnetic resonance (RMN) on ALS 300.
* INSERM U556 / Industry Edaptechnomed
Engineer Assistant: Study of the effect of ultrasounds on the coagulation of blood vessels. (Animal experimentation, histological cups, micro-volume, inclusion-colouring, optic reticule for measurements).
* International agency for Research on Cancer (IARC)
Senior technician: Study of Amifostine on human cancerous cells.
(Technology of extraction of DNA, Purification, RT-PCR, PCR, Electrophoreses, Northern Blot, Western Blot).
-
Center International
- Ingenieur
2001 - 2006
CIRC (Center International of Research for Cancer):
-------
Responsible for the development of descending of mice transgenic,
Coordination of experimentation for amelioration of techniques to determine protein SER249 of gene TP53: drug molecule-test of the study of the cancer of the liver: pharmacokinetic, dose confirmation and efficacy, in-vitro test,
At the same time assist director study in the realization with this molecule for tolerance and optimal condition to prescription (notebook preparation, participation of briefing and meeting with project team, CRF capture, reporting of adverse event, report, ..)
University Claude Bernard Lyon I:
: set up by practical jobs for the students of professional licences of Chemistry, Biochemistry and Biology (Plant, Biocell Biology, Microbiology, Genetics and Immunology, HPLC).
Center of Nuclear Magnetic Resonance (RMN):
Senior technician: loaded with relations with the different laboratories of chemical, medical and pharmaceutical research. Analysis of samples by nuclear magnetic resonance (NMR) on ALS 300.
Engineer Assistant: study of the effect of ultrasounds on the coagulation of blood vessels. (Animal experimentation, histological cups, micro-volume, inclusion-colouring, optic reticule for measurements).
International agency for Research on Cancer (IARC):
Senior technician: Study of Amifostine on human cancerous cells.
(Technology of extraction of DNA, Purification, RT-PCR, PCR, Electrophoreses, Northern Blot, Western Blot).
-
Center International
- Ingenieur
2001 - 2006
CIRC (Center International of Research for Cancer):
-------
Responsible for the development of descending of mice transgenic,
Coordination of experimentation for amelioration of techniques to determine protein SER249 of gene TP53: drug molecule-test of the study of the cancer of the liver: pharmacokinetic, dose confirmation and efficacy, in-vitro test,
At the same time assist director study in the realization with this molecule for tolerance and optimal condition to prescription (notebook preparation, participation of briefing and meeting with project team, CRF capture, reporting of adverse event, report, ..)
University Claude Bernard Lyon I:
: set up by practical jobs for the students of professional licences of Chemistry, Biochemistry and Biology (Plant, Biocell Biology, Microbiology, Genetics and Immunology, HPLC).
Center of Nuclear Magnetic Resonance (RMN):
Senior technician: loaded with relations with the different laboratories of chemical, medical and pharmaceutical research. Analysis of samples by nuclear magnetic resonance (NMR) on ALS 300.
Engineer Assistant: study of the effect of ultrasounds on the coagulation of blood vessels. (Animal experimentation, histological cups, micro-volume, inclusion-colouring, optic reticule for measurements).
International agency for Research on Cancer (IARC):
Senior technician: Study of Amifostine on human cancerous cells.
(Technology of extraction of DNA, Purification, RT-PCR, PCR, Electrophoreses, Northern Blot, Western Blot).
-
Center International
- Ingenieur
2001 - 2006
CIRC (Center International of Research for Cancer):
-------
Responsible for the development of descending of mice transgenic,
Coordination of experimentation for amelioration of techniques to determine protein SER249 of gene TP53: drug molecule-test of the study of the cancer of the liver: pharmacokinetic, dose confirmation and efficacy, in-vitro test,
At the same time assist director study in the realization with this molecule for tolerance and optimal condition to prescription (notebook preparation, participation of briefing and meeting with project team, CRF capture, reporting of adverse event, report, ..)
University Claude Bernard Lyon I:
: set up by practical jobs for the students of professional licences of Chemistry, Biochemistry and Biology (Plant, Biocell Biology, Microbiology, Genetics and Immunology, HPLC).
Center of Nuclear Magnetic Resonance (RMN):
Senior technician: loaded with relations with the different laboratories of chemical, medical and pharmaceutical research. Analysis of samples by nuclear magnetic resonance (NMR) on ALS 300.
Engineer Assistant: study of the effect of ultrasounds on the coagulation of blood vessels. (Animal experimentation, histological cups, micro-volume, inclusion-colouring, optic reticule for measurements).
International agency for Research on Cancer (IARC):
Senior technician: Study of Amifostine on human cancerous cells.
(Technology of extraction of DNA, Purification, RT-PCR, PCR, Electrophoreses, Northern Blot, Western Blot).
