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Pharma and CROs
- Clinical Project Manager Hemato and Oncology Clinical Trials within Pharma and CROs
2005 - maintenant
CLINICAL RESEARCH
‐ Successful management of Phase I, II and III onco – hematology full scope projects with up to 500 patients, 16 countries, and 90 sites involved, with vendors, financial, and resources management.
‐ Lead and motivate cross functional study teams and sub- teams to deliver projects within the agreed timelines and budget, and in compliance with the required quality.
‐ Effectively oversee and manage CROs.
‐ Report project status internally and externally as appropriate.
‐ Actively participate at CRAs, Investigators and BID defense meetings
‐ Contribute to the preparation and review of study documents (Protocols, ICFs, CRF, CSR etc,), specific execution plans (Project, Safety, Monitoring plans, etc...); WP and vendors specifications (IVRS, Labs; QoL…).
‐ Actively contribute to the regulatory submission (EMA and FDA) of Sponsor and Investigator Initiated Trials (IIT) supporting Marketing Authorization Application.
‐ Provide support to cooperative group for editing interim and final CSR according to GCP.
‐ Ensure the compilation and maintenance of study documentation (e.g., TMF) including CSR appendices, 120day safety updates.
‐ Actively participate in the development of clinical development plan and Target Product Profile.
QUALITY ASSURANCE
- Ensure clinical trials and related documentation inspection readiness, overseeing adherence and compliance to study documents/Plans, WP and SOPs, GCP guidelines and regulatory requirements.
‐ Perform quality review of all study documents including clinical study reports with TLG quality review.
‐ Collaborate in the preparation of up to 50 Investigators Site Audits and Vendors Audits.
‐ Ensure adequate and timely CAPA follow up and collection of supporting documentation of these audits.
‐ Assist in the preparation of regulatory inspections and participate to a GCP MHRA inspection.
‐ Provide advice and support for process improvement, study documentation maintenance and inspection preparedness to collaborative groups implementing IITs.
‐ Participate in process improvement initiatives, including Trial Master File Quality Review processes.
‐ Act as subject matter expert for GCP.
‐ Support the Clinical Development Director for the implementation of operational processes.
‐ Development, implementation and maintenance of Standard Operating Procedures, forms and templates.
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CROs
- International CRA (CRA, Senior and /Lead CRA)
2001 - 2005
CLINICAL RESEARCH
‐ Organization, setting and monitoring of Phase I, II, III of onco-haematology clinical trials.
‐ Contribute in the development of budgets ensuring project objectives and maximizing profitability.
‐ Lead and motivate CRAs to deliver projects on time, within budget and with high quality.
‐ Develop, review and edit clinical trial related documentation including but not limited to; Case Report Forms, Informed Consent Forms, study specific handbooks, guidelines and checklists.
‐ Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required.
‐ Report project status internally and externally as appropriate.
‐ Conduct monitoring visits to ensure that the trials are conducted and documented properly according to GCP standards and Sponsors SOPs.
QUALITY ASSURANCE
‐ Prepare and conduct audit support visits, and ensure adequate and timely CAPA follow up.
‐ Support the Clinical Operation Director for the implementation of operational processes.
‐ Development, implementation and maintenance of Standard Operating Procedures, forms and templates.
‐ Participate in various quality initiatives for process improvement.
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CROs
- Account Executive France
2001 - 2005
‐ Represent the company to prospective clients, and identify appropriate clients and opportunities. Collaborate in the development of Request for Information and Request for Proposal.
‐ Develop and update Data Base of prospective clients.
‐ Identify appropriate trade shows, conferences, and conventions and actively participate.
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World Health Organization and the Joint United Nations Programme on HIV/AIDS
- Vaccine Clinical Trial Specialist
1997 - 2001
CLINICAL RESEARCH
‐ Collaborate in the development, revision and update of "National AIDS Vaccine Plans" for developing countries submitted to HVI (The HIV Vaccine Initiative of the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS)).
‐ Review of research proposals and HIV preventive vaccine clinical trial protocols.
‐ Organization and facilitation of workshops and scientific meetings.
‐ Responsible for administrative issue of HVI, including budget and development and update of the HVI website.
QUALITY ASSURANCE
‐ Development of Standard Operating Procedures for CRAs/monitors and investigators involved in clinical trials sponsored by the WHO Special Programme for Research and Training in Tropical Diseases (TDR) and HVI.
‐ Training of monitors, investigators and members of ethical review committees in developing countries on GCP.
‐ Responsible for the development of the UNAIDS Guidance Document "Ethical considerations in HIV preventive vaccine research".
‐ Contribute in the development of the WHO/TDR "Operational Guidelines for Ethics Committees that Review Biomedical Research".
‐ Perform an Ethical review of phase III efficacy HIV vaccine clinical trial.
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Pasteur Merieux
- International CRA
1991 - 1997
CLINICAL RESEARCH
‐ Organization, setting and monitoring of Phase I, II, III of vaccine and onco-haematology clinical trials.
Countries: France; Belgium, Israel, Italy, Switzerland, Thailand, Taiwan, Vietnam.
‐ Develop, review and edit clinical trial related documentation including but not limited to; Case Report Forms, Informed Consent Forms, study specific handbooks, guidelines and checklists.
‐ Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required.
‐ Report project status internally and externally as appropriate.
‐ Conduct monitoring visits to ensure that the trials are conducted and documented properly according to GCP standards and Sponsors SOPs.
QUALITY ASSURANCE
‐ Prepare and conduct audit support visits, and ensure adequate and timely CAPA follow up.
‐ Support the Clinical Operation Director for the implementation of operational processes.
‐ Development, implementation and maintenance of Standard Operating Procedures, forms and templates.
‐ Participate in various quality initiatives for process improvement.
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Hoescht Roussel
- Medical Representative
1990 - 1991
