Sosie D. Email & Phone Number

Brussels, Be

Copenhagen Denmark

Brussels Metropolitan Area

Mechelen, Flemish Region, Belgium

Lead Clinical Data Manager for global clinical trials /researchResponsible for the clinical SDTM database for clinical studies and serve as the Point of Contact towards all involved parties and towards the client (Pharma and Biotech Industries)•Set-up study•Review and testing of the Data Collection Tool •Create eCRF completion Guidelines •Development of Data Management Plan•Defining and validating the SDTM cleaning package •Validation of the SDTM database based on the applicable implementation guide and agreed standards with the client. •Define and agree on (customized) progress and status reports •Create/review the Data Transfer Agreements with all External Data Providers •Coding of therapies and medical events Serious Adverse Event reconciliation •Create the Protocol Deviation Criteria List and handle/detect the Protocol Deviations•Processing of (Interim) Database Locks and provide the necessary data for Safety Reviews, DSMBs, Safety Committees Ensure the submission package is complete for your project

Belgium

Main point of contact for clinical trial sites. Responsible for managing site related operational activities and issues. Responsible for the clinical trials project deliverables Site monitoring and regulatory

Belgium

Research: (Ecotoxicology) An analytical approach was used to evaluate mixed chemical pollutants in the environment, employing a test species highly sensitive to pollutants to assess survival rates. The results were analyzed using the R programming language for statistical analysis.

Belgium

Lab experimentsData Analysis

Operating Room exposure assist for minor and major surgeries •(Total Abdominal Hysterectomy Bilateral Salpingo Oophorectomy TAHBSO, Explore Laparotomy, Amputation etc...)CardiologyOncologyDelivery RoomICUNICUERInfectious Unit

Master Of Science - Ms, Fac Bioscience Engineering

Graduated

Education record

Global Health