Clinical and R&D Project Manager

• Apr 2023 - Present

- Management and/or coordination and execution of research and development projects in the field of health products and clinical studies (including laboratory techniques). - Participation in the implementation and follow-up of R&D projects and clinical studies. - Follow-up and reporting on project progress to internal and external stakeholders. - Regulatory and ethical monitoring to ensure that projects comply with current standards. - Management of project deadlines and budgets. - Management and/or coordination and execution of research and development projects in the field of health products and clinical studies (including laboratory techniques). - Participation in the implementation and follow-up of R&D projects and clinical studies. - Follow-up and reporting on project progress to internal and external stakeholders. - Regulatory and ethical monitoring to ensure that projects comply with current standards. - Management of project deadlines and budgets.

Clinical Site Manager

• Oct 2020 - Sep 2022

Phase III, Cell therapy (CAR-T), Multiple Myeloma. Phase IV, Standards of care (SOC), Multiple Myeloma. Phase II, Paediatrics, Chemotherapy, Acute Lymphatic Leukemia. Major achievements: - An audited clinical site with no major findings. - Meeting timelines while providing high-quality deliverables for quarterly intermediate analyses. - Low rate of serious adverse events observed with trial patients. - Clinical trials qualified for the following phases. - High-quality results shared at world-renowned conferences. Responsibilities: - Development of an online platform providing clinical trial participants with relevant information, informing potential participants about available trials, and giving them insight into a number of medical conditions. - Facilitating audits and resolution of audit findings, issue escalation, CAPA implementation and follow-up. - Management of the logistics of Investigational New Drugs (IND) and clinical kits on a European scale. - Management of primary and secondary packaging activities, (re)-labelling, storage and optimization of the supply and distribution strategy in compliance with regulations and budget. - Budget management (Forecasts and Actuals). - Medical training and education of investigative site staff. - Mentoring junior CRAs, and leading observation and performance visits. - Monitoring clinical trials in investigative sites to ensure sponsor and investigator obligations are met and are compliant with applicable local and ICH-GCP guidelines. - Reviewing and verifying the accuracy of clinical trial data collected and query resolution. - Providing regular site status updates to local and global trial management. Technical Skills: - Clinical Trial Management System: Medidata CTMS. - EDC (eCRF): Medidata RAVE. - IVRS/IWRS/RTSM: Bracket. - Veeva Vault eTMF. - Electronic Medical Records (EMR). Vendor Experience: - Central Lab Services: Hematogenix, LabCorp. - Courier: DHL. Show less

Clinical Research Associate (CRA II)

• May 2019 - Oct 2020

Phase III, Nuclear Medicine, Renal Cell Carcinoma, Telix Pharmaceuticals. Phase Ib/II, Metastatic Renal Cell Carcinoma, AVEO Pharmaceuticals. Retrospective, Nuclear Medicine, Hepatocellular Carcinoma, Advanced Accelerator Applications. Phase I/II, Active chronic non-infectious uveitis (ophthalmology), EYEVENSIS. Major achievements: - Building-up strong, professional relationships with both investigative sites and trial sponsors. - Increasing sites' motivation and patient enrollment after a period of inactivity. - Assuming a backup role to Clinical Project Manager when needed. - Low rate of adverse and serious adverse events observed with trial patients. - Clinical trials qualified for the following phases. - High-quality results of the clinical trials shared at world-renowned conferences. Responsibilities: - Initiating clinical trials at investigative sites, and site personnel oversight of the proper conduct of clinical trials. - Vendor selection and order follow-up and management. - Management of the logistics of Investigational New Drugs (IND) and clinical kits on a European scale. - Management of primary and secondary packaging activities, (re)-labelling, storage and optimization of the supply and distribution strategy in compliance with regulations and budget. - Budget management (Forecasts and Actuals). - Medical training and education of investigative site staff. - Mentoring junior CRAs, and leading observation and performance visits. - Monitoring clinical trials in investigative sites to ensure sponsor and investigator obligations are met and are compliant with applicable local and ICH-GCP guidelines. - Reviewing and verifying the accuracy of clinical trial data collected and query resolution. - Providing regular site status updates to local and global trial management. Vendor Experience: - EDC (eCRFs): Ennov Clinical, Clindex. - Central Lab Services: TDL, Oncodesign. - Central Imaging Services: Duke Reading Center. - Courier: DHL, Marken. Show less

Drug Safety and Medical Information Officer

• Nov 2018 - May 2019

• Detection, understanding, and prevention of unwanted side effects. • Management of cases of pharmacovigilance, cosmetovigilance, materiovigilance, and nutrivigilance transmitted through spontaneous notifications or clinical trials (receipt, documentation, data entry (AB-Cube SafetyEasy), coding (MedDRA), narrative writing, company comment, evaluation of causality and imputation (Begaud/French method, WHO-UMC system). • Hotline for pharmacovigilance and medical information during and off-working hours. • Weekly literature watch in French and international medical journals. • Signal Detection Report writing. • Product training and client advice. • Development and improvement of operations and procedures of AnticipSanté and its clients. Vendor Experience: Drug Safety Services: AB-Cube SafetyEasy. Show less

Clinical Research Associate in hematology-oncology (CRA I)

• Apr 2018 - Oct 2018

Efficacy study of Inecalcitol in combination with Decitabine in acute myeloid leukemia patients unfit for standard chemotherapy. Phase II, international multicentre study: 16 sites in France, 3 sites in Belgium, 3 sites in Germany, 15 sites in Spain, and 14 sites in the USA - Total: 115 patients. Responsibilities: - Monitoring visits to 5 sites and pharmacies in France, an average of 2 visits per week. - Remote monitoring of 5 sites in France and 7 sites in the USA. - Coordination with multinational CROs and subcontractors in Europe and the USA. - Regulatory drafting and submission: ANSM, CPP, WIRB (change of PI, protocol amendments, end of accrual notification, early termination of a clinical study). - Pharmacovigilance management of the study (processing, follow-up, documentation, transmission). - Site staff training on protocol amendments. - Study documentation maintenance (TMF, Investigator, and Pharmacist's Files on site, paper/electronic). - Design and maintenance of study trackers (Treatment cycles, scheduled blood tests, IMP receipt and dispensation, protocol deviations, SAEs, site logistics, and study documents). - Pharmacy relabeling campaigns, control of stock levels, storage condition, and prescription forms. - Biological test results processing, monitoring, and transmission to data management. - Site budget management, and invoicing proposals. - Close-out visits of 10 sites and pharmacies (France, Belgium, and the USA remotely). Vendor Experience: - Drug Safety Services: AB-Cube SafetyEasy. Show less

PhD Fellow

• Oct 2014 - Nov 2017

Research theme: Design, synthesis, and biological evaluation of small molecules inhibitors of anti-apoptotic proteins of the Bcl-2 family.Research grant: ARC Foundation for Cancer ResearchSupervisors: Dr Fanny ROUSSI, Dr Sandy DESRATResponsibilities:- Gram-scale multi-step biomimetic organic synthetic pathway, molecule purification, and structural characterizing.- Batch production optimization: toxicity minimization and cost optimization.- Pharmacomodulations, Structure-Activity Relationship (SAR) analysis.- Implementation and robotization of a fluorescence polarization inhibition assay.- High throughput screening and evaluation of biological activity through a fluorescence polarization inhibition assay.- Protein bioproduction and purification.- Protein-protein interaction study and analysis.- Data analysis and presentation: Author/co-author of 4 scientific articles, speaker at 3 European conferences.Technical skills:- Anton Paar MCP 300 polarimeter.- BUCHI Melting Point B-540.- RMN Bruker UltraShield managed by TOPSPIN 2.1.- UPLC-MS Bruker – MassLynx.- Chiral HPLC.- Flash liquid chromatography: CombiFlash© Rf 200i – TELEDYNE ISCO.Scientific Communications2017: “European Federation of Medicinal Chemistry, Young Medicinal Chemist Symposium”, Austria, Poster and flash oral presentation.2017: “Journée de l’Ecole Doctorale Innovation Thérapeutique”, France. Oral presentation.2016: “The 20th Meeting of Young Research Fellows in Cancerology”, France. Poster presentation.2016: "Journées de Chimie Organique", France. Poster presentation.2016: "Rencontres en Chimie Organique Biologique", France. Poster presentation.2015: “The 19th Meeting of Young Research Fellows in Cancerology”, France. Poster presentation.2015: “European School of Medicinal Chemistry”, Italy. Prize-winning poster and oral presentation. Show less

Teaching (theory and practice)

• Feb 2015 - Mar 2016

2nd-year students, “Bioreactors” module, 80 hours

2nd-year of Masters internship

• Jan 2014 - Jul 2014

Supervisors: Dr. Fanny ROUSSI, Dr. Sandy DESRAT Responsibilities: - Gram-scale multi-step organic synthesis, purification, and structural characterizing. - Pharmacomodulations, Structure-Activity Relationship (SAR) analysis. - Bibliographic research, data analysis, and presentation. Supervisors: Dr. Fanny ROUSSI, Dr. Sandy DESRAT Responsibilities: - Gram-scale multi-step organic synthesis, purification, and structural characterizing. - Pharmacomodulations, Structure-Activity Relationship (SAR) analysis. - Bibliographic research, data analysis, and presentation.

Internship in Applied Bibliographic Research

• Apr 2012 - Jun 2012

Research theme: Confidential. Supervisor: Dr. Erwin VAN DEN BORN Research theme: Confidential. Supervisor: Dr. Erwin VAN DEN BORN

Internship in Biomedical Research

• Jul 2010 - Aug 2010

Research theme: Characterizing mi-RNA expression in Mononuclear Cells in Peripheral Blood (MCPB) of patients with Acute Coronary Syndrome (ACS). Research grant: NHS Foundation Trust Supervisors: Dr. Alison MORTON, Dr. Sara LANGRIDGE, Dr. Alex ROTHMAN Responsibilities: - Patient recruitment for biomedical research. - Blood sampling and sample racking in the biorepository. - Total and mi-RNA extraction, characterizing, and quantification. - Data analysis and interpretation. Technical skills: - Beckman Coulter Biomek FXP Laboratory Automation Workstation monitored by Biomek Software. - Beckman Coulter Paradigm Detection Platform managed by SoftMax Pro 6.1. - PAXGene Blood RNA System, PreAnalytix. - Taqman Low-Density Array RT-qPCR (SDS miRNA Human_A TLDA Card & HT 7900 Fast Real-Time PCR, Applied Biosystems). - GraphPad Software, Inc., San Diego, CA. - Thermo Scientific Nanodrop 2000 Spectrophotometer. - BIO-RAD Mini-PROTEAN ® Tetra System. Show less

Internship in Pharmacy Practice

• Jul 2008 - Sep 2008