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LYSARC
- Clinical Project Manager
2012 - maintenant
Mantle Cell Lymphoma, Phase III and II trials, France, Belgium, 300 patients for each.
Follicular lymphoma, Phase III trial, France, Belgium, Germany, Italy, 540 patients.
Hodgkin lymphoma, Phase I trial, France, 25 patients.
Responsibilities:
Study budget estimation, partners’ agreements, CRAs trainings, hospital Agreements, nonprofit-organizations agreements, regulatory submissions, Site Initiation Visits, IP and IVRS management, sites documents elaboration, subject recruitment follow-up, monitoring reports review. Working with Heads of Departments (monitoring, statistics, Regulatory Affairs, Data Management, Pharmacovigilance, QA), Principal Investigators, Investigators, CRAs.
Participation in CTMS solution choice.
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PX' THERAPEUTICS
- Clinical Project Manager
2010 - 2012
HIV vaccine, 2 Phase I trials, UK, one site for each, 48 and 50 subjects for each.
Responsibilities:
- GCPs set up in the company (SOPs and Charter writing, application of the SOPs),
- Clinical trial: timelines planning, site selection, CRO selection, CRO validation visit, CRO contract, collaboration in protocol, ICF, CRF and Diary Card elaboration, investigational product management, Health Authority & EC submissions, preparation of the training materials and working documentation for investigators and CRAs, training given to CRAs and investigators, subject recruitment follow-up, monitoring reports review, study termination declaration and TMF archiving,
- working with Project Coordinator, project partners, Project Planner, Principal Investigator, Investigators, CRO stakeholders: Medical Writer, Data Manager, Statistician, Regulatory Affairs Manager, Pharmacovigilance, Clinical Operation Manager, QA manager, CRAs.
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Kelly Scientifiques
- Clinical Trial Manager
2008 - 2010
Clinical Trial Manager Kelly Scientifique for sanofi-pasteur (Marcy l’Etoile – France).
Annual Flu vaccine: Phase II trial, France, four sites, 130 subjects.
Japanese Encephalitis vaccine: 5 Phase III trials, Thailand, Taiwan, India, four to six sites for each trial, 300 to 450 subjects for each trial.
Responsibilities:
- Management of the clinical trials: site selection, pre-selection visits, CRO selection, collaboration in protocol, ICF, CRF and Diary Card elaboration, investigational product management, EC submission, preparation of training materials and working documentation for investigators and CRAs, trainings given to CRAs and investigators, subject recruitment follow-up, monitoring reports review, IP and IVRS management, study termination declaration and TMF archiving,
- Working with Clinical Trial Leader, Clinical Program Manager, Data Manager, Statistician, Regulatory Affairs Manager, CRO stakeholders (Clinical Operation Manager, CRAs), investigators,
- Respecting very tight deadlines.
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QUINTILES
- CRA
Durham
2005 - 2008
Customer managed to sanofi-aventis france (Gentilly and Paris – France)
Anti-infective (Chronic Bronchitis), cardio-vascular risks due to abdominal obesity, oncology (oesophagus, head and neck, prostate), diabetes (I and II); customer managed to Johnson & Johnson (Issy les Moulineaux), therapeutic areas: psychiatric, pain, hepatitis C.
Monitoring of Phases II, III, IV clinical trials to ICH / GCP and internal / external SOPs. Acting Lead Trial Manager on the pain project.
Responsibilities:
- Centres’ selection, Pre-selection visits, Investigators’ meeting (presentation of the protocol), set-up visits, close-up visits, assisting in study termination
- Monitoring and source data verification, drug accountability, investigator payments
- Preparation and maintenance of investigator site files and trial master files
- Working with investigators, medical advisers, statisticians and project managers
- Teaching monitoring procedures and practice to CRAs
- Preparation and circulation of weekly status reports
- Ethical Committees folders’ submissions
- Audit preparation, audit visit on investigator’ site
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MEDIBRIDGE
- CRA
2005 - 2005
Co-ordination and monitoring of Phases IV and Interventional non-pharmacological clinical trials to ICH / GCP and internal / external SOPs.
Dental: uletic inflammation and dental plate, chronic parodontitis; Fibromyalgia: psychological and behavioural assessments by gait analysis.
Responsibilities:
- Monitoring and source data verification, drug accountability, investigator payments
- Preparation and maintenance of investigator site files and trial master files
- Working with investigators, medical advisers, statisticians and project managers
- Teaching monitoring procedures and practice to CRAs
- Preparation and circulation of weekly status reports
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GECEM
- CRA
Rennes
2004 - 2005
Co-ordination and monitoring of Phases III and IV clinical trials to ICH / GCP and internal / external SOPs.
Acute Diarrhea (Beaufour Ipsen Pharma), Paediatric (vaccine) -study on line- (GSK), Hypertension (Menarini), Chronic Obstructive Pulmonary Disease (GSK), Ophthalmology (Pfizer)
Responsibilities:
- Centres’ selection, Pre-selection visits, Investigators’ meeting (presentation of the protocol), set-up visits, close-up visits, assisting in study termination
- Monitoring and source data verification, drug accountability, investigator payments
- Preparation and maintenance of investigator site files and trial master files
- Working with investigators, medical advisers, statisticians and project managers
- Teaching monitoring procedures and practice to CRAs
- Preparation and circulation of weekly status reports
- Ethical Committees folders’ submissions
- Audit preparation, audit visit on investigator’ site
