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CEREP
SAINT-QUENTIN
maintenant
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PRA Health Sciences
- Project Manager-feasibility
2015 - maintenant
Provide feasibility assessments for new business opportunities or awarded studies.
Coordinates Feasibility and/or Site Identification activities, including communication with the customer and timeline management.
Designs Feasibility study specific document and questionnaires for collection of metric.
Facilitates Site Identification activities, including review of Confidential Disclosure Agreements, and Potential Investigator Questionnaires.
Liaises with Clinical Research Associates globally to synchronize and coordinate Feasibility and Site Identification, providing training when needed.
Performs storage, update, QC, and analysis of feasibility data, including interpretation of feasibility text for presentations and feasibility reports.
Feasibility report writing.
Develops, implements, and manages feasibility analysis systems and support collection of feasibility data.
Provides leadership and oversight of team.
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PRA international
- Clinical research Scientist - Feasibility specialist
2012 - 2015
Provide feasibility assessments for new business opportunities or awarded studies.
Coordinates Feasibility and/or Site Identification activities, including communication with the customer and timeline management.
Designs Feasibility study specific document and questionnaires for collection of metric.
Facilitates Site Identification activities, including review of Confidential Disclosure Agreements, and Potential Investigator Questionnaires.
Liaises with Clinical Research Associates globally to synchronize and coordinate Feasibility and Site Identification, providing training when needed.
Performs storage, update, QC, and analysis of feasibility data, including interpretation of feasibility text for presentations and feasibility reports.
Feasibility report writing.
Develops, implements, and manages feasibility analysis systems and support collection of feasibility data.
Provides leadership and oversight of team.
Team management
Ability to manage multiple projects simiultaneously
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For Drug Consulting
- Trainee
2011 - 2011
I did 3 Clinical site initiations (2 in French, 1 in English), Slide preparation putting forward the important points of the protocol: ICF, selection criteria, AE and SAE...
CRF and eCRF monitoring (particularly paying attention to ICF, selection criteria, AE/SAE, respect of protocol and GCP guideline).
Solving problems related to non GCP-conform ICF, AE/SAE report, respect of protocol...
TMF set up, ICF, protocol review and amendment
ICH-GCP
Monitoring report.
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PRA international
- In house CRA
2011 - 2012
I am be the primary contact with clinical trials investigator sites during site start-up activities (i.e. site identification, selection and activation)
• I am responsible for working with investigative sites to collect the required investigator and regulatory documents for a study
• I Work together with CRA’s and Project Manager to meet deadlines
• I work with investigative sites to negotiate and finalize investigator contracts and budgets
• Ensure the maintenance of site address and personnel information in the study database is kept up to date
• I have responsibility for final reviews of translated documentation, customisation of the local documentation and preparation and submission to Ethic Committee - initial submission and amendments
• I have regular contact with internal/external teams within a international environment
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RMIT Universiaty
- Research Fellow
2009 - 2010
Responsible for the development and execution of research program both in vitro and in vivo experimental models to progress in the complexion of a long term project.
Member at the Animal Ethic Committee.
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Howard Florey Institute
- Senior research officer
2006 - 2009
Contribute to the planning and coordination of behavioral studies. Provide intellectual input into the design and analysis of experiments conducted at the INF
Key responsibilities involved:
- Coordinate and Conduct experiments for the INF.
- Data analysis, statistic analysis (occasionally assist student with their statistical analysis)
- Write ethic protocols, technical report and SOPs
- Organize project timetable to enable project deadlines
- Handing and processing of biological samples, records of experimental conditions and results in accordance with Australian code of Practice for the care and use of animal for scientific purposes.
- Customer services: Provision of assistance to students and/or customers in the development of experiments. Liaison with clients and User of the INF facility.
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CDCO/ Monash university
- Scientist
2005 - 2006
General Responsibilities
• Contribute to the planning and coordination of pharmacokinetic studies in conjunction with the biopharmaceutics section leader
Specific Duties
• Conduct surgery, cannulation, dosing and sampling to support pharmacokinetic studies in small animals (rats and mice)
• Assist with the data analysis and compilation of data
• Assist the biopharmaceutics section leader in the preparation of animal ethics protocols
• Assist in updating SOPs associated with small animal studies
• Effectively manage time to enable project deadlines and timelines to be met
• Assist with research activities as directed
• Ensure that studies are conducted in accordance with Monash University OHSE and animal ethics requirements
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Brain Science Institute
- PhD
2003 - 2006
Setup, conduct and monitor 3 phase I trials from start to finsih. Including, Ethic submission, Protocols, CRF and ICF writing, monitoring trials until close-out (full cycle) all conducted, recorded and reported in accordance with the protocol and Australian regulations.
Statistical analyses and Report writing.
