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MSD France
- Chef de Projets Etudes Cliniques
Courbevoie
2013 - maintenant
Clinical Trials phases I in Oncology (NSCLC – all solid tumors) (6 and 4 sites)
o Study start up : feasibility validation visits, strong interaction between HQ, GMA and French team to plan study initiation in timely manner
o Ethical committee submission
o Administrative, logistic and operational follow-up
Clinical Trial phase II in Pneumology / Asthma (7 sites)
o Administrative, logistic and operational follow-up
o Ethical committee submission
o Ongoing monitoring visits
o Strong interaction between Head Quarter and French team (CRAs, CTC, Regulatory department)
Clinical Trial phase IiI in Pneumology / COPD (20 sites to validate)
o Study start up : feasibility validation visits, strong interaction between Head quarter and French team to plan study initiation
Clinical Trials phases III in Hepatology (16 sites)
o Administrative, logistic and operational follow-up
SME Clinical Specimen Management
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Covance pour MSD
- Attachée de Recherche Clinique
2011 - 2013
Clinical Trial phase II in Pneumology / Asthma (7 sites)
- CRA Lead
o Study start up : feasibility validation visits, strong interaction between Head quarter and French team to plan study initiation
o Ethic committee's submission
o Financial negotiations, contracts, CNOM submission
o Investigators' Meeting participation
o Transversal communication with different departments: medical affairs, regulatory, finance.
o CRA team supervision: HQ point of contact for transmission of information to CRA (protocol, training, timelines...)
o Informed Consent Form internal coordination
Clinical Trials phase I-II in Oncology
o Feasibility Site Validation visits
Clinical Trials phases III in Hepatology
- CRA Lead for 1 study (5 sites)
o Administrative, logistic and operational follow-up
o Ethical committee submission
o Ongoing – close out visits
o Strong interaction between Head Quarter and French team (CRAs, CTC, Regulatory department)
- CRA
o Ongoing monitoring and close out visits
o Amendment implementations
o Administrative, logistic and operational follow-up for all these studies
Clinical Trial phase III in Immunology
o Monitoring visits as unblinded monitor at the pharmacy, Close out visit
Clinical Trial phase III in Rheumatology
o Ongoing monitoring visits (site and pharmacy) and administrative, logistic and operational follow-up
o Close out visits
Workgroup on patient’s informed consent form renewal
,
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Clinact pour Schering Plough
- Attachée de Recherche Clinique
2009 - 2010
Clinical Trials phases III in Hepatology
- CRA Lead for 1 study (5 sites)
o Study start up and operational follow-up: strong interaction between Head quarter and French team (CRAs, CTC, Regulatory department)
o Ethic committee’s submission (initiation and amendments)
o Administrative, logistic and operational follow-up
o Initiation visit and ongoing monitoring visit
- CRA
o Initiation, Ongoing monitoring visits and Close out visits
o Administrative, logistic and operational follow-up for all these studies
- Coordinator for IMP recall for 3 impacted studies
o IRBs and sites notifications
o IMPs replacement
1 Clinical Trial phase III in Immunology
o Study Initiation and monitoring visits as unblinded monitor at the pharmacies
1 Clinical Trial phase III in Pneumology
o Preliminary Feasibility Assessments
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Pierre Fabre Médicament
- Attachée de Recherche Clinique stagiaire
Castres
2009 - 2009
Coordinator and Clinical Research Associate trainee
In 2009 (January to June)
2 Clinical Trials, phase II, on the Central Nervous System
- Participation of the project management team for the initiation of an international phase II study (10 countries, 410 patients)
o Participation in writing study documents (protocol, CRF, patient informed consent)
o Participation in ethic committee’s submission
o Validation of screenshots, participation in user tests of electronic diary
o Study's questionnaires management (availability, translation into local languages, costs)
o Trial Master File implementation
- Site activity (monocentric study, Switzerland, 120 patients)
o Co-monitoring visits
o Participation in project staff's meetings (clinical team, data-management)
- Site close-out visit
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Pierre Fabre Médicament
- Attachée de recherche clinique stagiaire
Castres
2008 - 2008
Stagiaire dans le département des Opérations cliniques internationales, sur 2 études de phase II, SNC
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Faculté de pharmacie Poitiers
- Étudiante en 6ème année de pharmacie + Master II essais cliniques
2008 - 2009
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CHU Bordeaux
- Externe
Talence
2007 - 2008
Externe en pharmacie à la Pharmacie dans le secteur des Essais Cliniques
-> gestion des receptions, dispensations et retour des médicaments experimentaux
Externe en pharmacie dans le service de Médecine Interne du Pr Pellegrin
