Clinical Trial Operation Manager for Late phase and real world studies
Since January 2016
Coordinateur de projet
Since June 2015
International Clinical Trial Coordinator
June 2015 --- December 2015
PHASE III INTERNATIONAL STUDY IN HEAD AND NECK CANCER • CRO & subsidiaries Management and oversight (country/site opening, budget, monitoring activities), • Safety management (SUSARs, reports, regulatory submissions), • Subject enrolment follow-up, • ICH/GCP and protocol compliance review, • Data management (overall management of activities to comply with timelines, patient data review)
Regional Clinical Trial Manager
March 2013 --- February 2015
• Study Launch: Study Document writing and revision (Protocol, monitoring plan, operating guidelines, CRF completion guidelines), CRF set-up, LOA revision, CRO Management for regulatory submissions, Investigator Meeting organization, site greenlights, initiation visits • Study follow-up: CRO Management and oversight, Quality control visits, site recruitment motivational visits, TMF Quality check, amendment regulatory submissions follow-up. • Study closure: CRO oversight, logistic for material management, TMF Quality check. • pre-approval inspections (PAI): Revision of TMF content and quality control of documents
Senior Clinical Research Associate (CRA)
December 2011 --- February 2013
• Identify, select, initiate and close-out appropriate investigational sites for clinical studies in France and Belgium. • Monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with ICON SOPs/WPs applicable regulations and the principles of ICH-GCP. • Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues.
Clinical Research Associate (CRA)
July 2010 --- November 2011
•Conducting site visits in FRANCE, UK and BELGIUM (initiation, monitoring, termination) •Ensuring adherence to FDA and ICH-GCP regulations •Ensuring adherence to local regulations •Ensuring the completion and collection of regulatory documents •Instructing the site staff in their roles and responsibilities in conducting clinical trials •Evaluating and reporting site performance and protocol compliance •Performing data verification of source documents •Performing CRFs collection •Performing product accountability and supply tracking •Ensuring completion and collection of SAEs •Assisting with data validation and resolution of queries •Ensuring compliance with CIRG SOPs.
Trainee in Clinical Research - Oncology department
January 2010 --- June 2010
•Monitoring, site initiation and site closing visits: Preparation of the visit, visit to the Pharmacy and tracking of investigational products, data monitoring of the Case Report Form versus source documents, update of Investigator and Pharmacist files, writing of monitoring visit reports. •Interim Safety Analysis: Patients data review and writing of Queries, tracking of Data Clarification Forms, review of Data Validation Plan. •Management of investigational products: Forecast of monthly needs for 5 countries, tracking of products stocks, products release. •Update of Monitoring Plan, writing of CRA and investigator newsletters. •Participation in project meetings and teleconferences. •ICH-GCP training.
Extern in Pharmacy
July 2009 --- September 2009
•Study designed to improve information intended for patients participating in clinical trials: Calculation of Flesh readability index on information sheets and statistical analysis of the results, Bibliographic review of improvements in patient information, Recommendations on the drafting of the information sheet. •Setting up, monitoring and analysis of the results of a safety Huber needles trial in the out-patient unit: Drawing up of an evaluation form, analysis of the results and choice of a device. • Assisting in the preparation of chemotherapies in sterile room class B, restocking of medical units and management of narcotic drugs. Following of the ward rounds in medical units, observation in the operating theatre, observation of scanners and treatments by radiotherapy.
Extern in Haemovigilance
April 2009 --- June 2009
•Professional practice evaluation: emergency calls for blood pockets, analysis of the results. •Causality investigations of adverse reactions occurring during transfusions: review of patient files and investigation with medical staff.
Trainee in Clinical Research - Cardio-metabolic department
July 2008 --- September 2008
•Writing in English of two drafts of publication: Bibliographic review of experimentation in the field, Drafting of publication with project managers, principal investigators and biostatisticians, and submission to the internal review committee.
Student in Pharmacy
January 2004 --- January 2007
•Dispensation of prescriptions, management of third-party payers (reimbursement by social security), receipt of orders, shelving, deliveries.
Docteur en Pharmacie in Recherche Clinique from Université de Bourgogne in 2010
Master 2 in PHARMACEUTICAL DEVELOPMENT AND CLINICAL TRIALS from Université de Poitiers in 2010