Client: Sanofi Early Development Clinical OperationsRole: Global Study Leader for 6 international Ph1/2 clinical trials in Oncology (Solid Tumors) in conduct/close-out phase.Completion of final DBL for 1 study.

PPD, part of Thermo Fisher Scientific - Clinical Research Group - Functional Service PartnershipsClient: Sanofi Early Development Clinical Operations- Since Mar 2024: Lead Global Study Manager on 4 Phase I/II international clinical trials in solid tumors, DBL & close-out phase (3 in-house trials and 1 outsourced trial). Central lab management SME.- Feb & Mar 2024: Lead Global Study Manager on an international Phase I/II Clinical Trial in Oncology (Solid tumors), start-up… Show more PPD, part of Thermo Fisher Scientific - Clinical Research Group - Functional Service PartnershipsClient: Sanofi Early Development Clinical Operations- Since Mar 2024: Lead Global Study Manager on 4 Phase I/II international clinical trials in solid tumors, DBL & close-out phase (3 in-house trials and 1 outsourced trial). Central lab management SME.- Feb & Mar 2024: Lead Global Study Manager on an international Phase I/II Clinical Trial in Oncology (Solid tumors), start-up phase.- May 2023 to Jan 2024: Global Study Manager on 2 Phase II international trials in Cell Therapy in start-up phase. Cell & Gene Therapy Taskforce contributor.Highlights:- Study Team Leader, in-house and outsourced international clinical trials- Leader of study start-up and close-out activities- Transversal oversight at program level- Development & Management of 'hybrid' study processes- Management of study timelines and budgets- Mentoring of a junior Global Study Manager - Cell & Gene Therapy Task Force contributor Show less

Global Study Manager on 2 Phase II international clinical trials in Cell Therapy in start-up phase.

Setup (until achievement of First Patient In) of a phase 3 international trial in breast cancer sponsored by Sanofi and conducted together with 3 Academic Partners.

Global Study Manager for 2 phase 3 international registration trials in Oncology (Multiple Myeloma) in conduct phase. Management of Central Imaging and Reading (IRC) from setup to DBL for interim analysis. Then Co-Lead Global Study Manager.

13-month apprenticeship working in tandem with the Lead Global Study Manager on an international phase 3 clinical trial in Multiple Myeloma which enrolled 470 patients in 21 countries across the globe.- Setup of Risk-Based Monitoring at global study level- Vendor management (digital tool)

Transgene is a French biotechnology company focused on discovering and developing immune-targeted therapies (therapeutic vaccines and oncolytic viruses) for the treatment of cancer and infectious diseases. As a Clinical Operations & CRA trainee, I:- Performed monitoring visits, produced reports, managed deviations and communicated with clinical sites (Phase I/Ib trial in chronic hepatitis B);- Was involved in several Clinical Project Teams for the setup of phase I/II oncology… Show more Transgene is a French biotechnology company focused on discovering and developing immune-targeted therapies (therapeutic vaccines and oncolytic viruses) for the treatment of cancer and infectious diseases. As a Clinical Operations & CRA trainee, I:- Performed monitoring visits, produced reports, managed deviations and communicated with clinical sites (Phase I/Ib trial in chronic hepatitis B);- Was involved in several Clinical Project Teams for the setup of phase I/II oncology studies;- Participated in vendor selection & management (CROs & CMOs);- Produced, translated and reviewed trial-related & essential documents and filed them in an eTMF system;- Took part in updating and reviewing Transgene SOPs;- Developed operational trackers for: patient compensation management; ISF/PSF documentation management.This experience allowed me to further develop my global understanding of Clinical Research by proactively and continuously interacting with the different actors involved in Clinical Operations & Supplies, Medical & Regulatory Affairs, Clinical Quality, Data Management, Pharmacovigilance, Biostatistics, Research, Toxicology, Purchasing... Show less

Treatment/pharmaceutical follow-up of hospitalized patients.

Clinical studies:- Provided assistance in clinical study initiation, conduct & management (Pediatrics)- Presented new trial protocols to the CIC Technical Committee (Pediatrics, Neurology, Inflammation)- Produced, reviewed and validated source document templates- Reported data on eCRFs & answered queries- Communicated both in French & English (orally and in writing)- Took part in a 3-day Investigator Meeting in Paris and initiated a Phase III trial on site… Show more Clinical studies:- Provided assistance in clinical study initiation, conduct & management (Pediatrics)- Presented new trial protocols to the CIC Technical Committee (Pediatrics, Neurology, Inflammation)- Produced, reviewed and validated source document templates- Reported data on eCRFs & answered queries- Communicated both in French & English (orally and in writing)- Took part in a 3-day Investigator Meeting in Paris and initiated a Phase III trial on site (Pediatrics)Pharmaceutical management of clinical trials:- Handled IXRS (randomization, treatment allocation)- Followed-up patients, managed and dispensed IMPs- Assessed patient compliance- Provided patients with information & adviceQualified in ICH-GCP. Show less

Part-time student job in a Community Pharmacy for two years:- Dispensed drugs and provided patients with advice- Assembled & controlled prescriptions- Managed stock & orders- Communicated with patients, physicians and suppliers- Carried out medication deliveries to patients

Developer & Designer of the "Gîte de la Mésange" vacation home rental website, Gîte de France n°2079 in Saverne (Alsace), France.

Provided private English lessons to students preparing for the Strasbourg International High School "Les Pontonniers" entrance exams.Provided academic support to French High School students in Mathematics, Physics and Chemistry.

Harvested tobacco in July & August 2007 and 2008.