Saïd Taibi Email & Phone Number

Responsible for developing and maintaining the relationship with the site and ensuring they are equipped with all necessary supplies to perform study procedures. • Perform all site management and monitoring activities at a clinical site(s) in accordance with study protocol, standard operating procedures and associated plans, and relevant local and internal regulations, legislation and ICH/GCP guidelines. • Single point of contact for assigned sites for the lifecycle of the study in addition to developing and maintaining the relationship pre and post the study timelines including feasibility, study-startup, essential document/TMF maintenance etc. • Support the site and other internal CSL Behring functional areas such as Safety/Pharmacovigilance, Regulatory, Clinical Trial Supply, etc. • Guarantee the adequacy, the reliability and quality of the data collected from sites and participate in the quality control processes. • Conduct site qualification visits (pre-study visits), site initiation visits, interim site visits and site close out visits, in accordance with SOPs, ICH/GCP, Protocol(s)/Amendment(s), Standard Operating Procedures (AC and CSL SOPs) Code of Federal Regulations (CFR) Good Clinical Practice (ICH GCP), and local regulations. • Ensures all project specific training is conducted and documented for the site throughout the life of the trial as well as all assigned sites are trained and compliant with requirements of the study protocol, informed consent process, data collection requirements, IP management, SAE reporting requirements.

Région De Paris , France

Responsible to ensure all task performed ensure the rights, safety and well-being of human study subjects are protected and the scientific integrity of the data collected• Site evaluation visits, initiation visits, either on site or off site monitoring visits or both, study close-out visits, involvement in study feasibility • Collecting regulatory documents, translations of key documents, involvement in regulatory & ethics submissions• Contract and budget discussions with sites and GSK study team communication, • AE/SAE reporting, maintaining study files (paper and electronic), • Keeping all study tracking systems up to date with current data, archiving of sponsor documents and site payments.

Région De Paris , France

In charge of many multicentre national and international cohorts and phase II-III studies at HIV-infected patients.• Designed a protocols, eCRFs and informed consent form (ICF). • Prepared and followed through on submissions to the Ethics Committee and the relevant Competent Authorities (CPP – ANSM – CCTIRS). • Studies feasibility, selection, Initiation, Monitoring, Close-out visits. • Determination of the patients/biological samples circuit. • Budget management, publication of tender and choice of providers. • Drafted procedures relating to logistics of clinical trials, newsletters and meeting reports. • Management of queries, serious adverse events (SAE) and clinical trial treatment. • Lead country investigators meetings, scientific board and data safety monitoring board (DSMB).

Région De Paris , France

Clinical research associate on an Observational studies and cohorts in VHI patients infected.• Performed initiation and monitoring. • Verified protocol and ICH GCP compliance. • Ensured procedures were in place for appropriate optimization of patients into the clinical study. • Appointed main contact for investigators. • Reviewed CRFs and performed Source Data Verification activities. • Discussed corrective actions and administrative issues.

Bichat Claude Bernard Hospital – Paris

I worked on 2 major national studies at HIV-infected patients. I was also in charge of the general coordination of trials and management of a bank of biological samples as well.• Patient selection and enrollment (inclusion/exclusion criteria). • Visits schedule based on protocols requirements. • Data collection and reporting on eCRF, modification and correction. • Adverse events reporting and queries to sponsor and CRO. • Samples storage and shipment to the appropriate laboratory

Lariboisiére Hospital – Paris

I coordinated clinical studies in cardiology and medical devices (Stent).• Participated in initiation of visits at assigned clinical sites as needed. • Prepared site monitor visits, site visit reports and follow-up letters and CRF completion. • Collected patient questionnaires, lab samples and returned drogues. • Participated in patient recruitment for clinical trials

Algeria

Veterinary practitioner on treatment, well-being of animals and fostering animal healthcare.• Conducted detailed examination of animals to find out the possible symptoms and prescribed medication or treatment. • Performed a variety of surgeries. • Assisted and educated the cattle raisers about general feeding procedures and other sanitary measures in order to promote animal healthcare. • Trained and supervised personnel who took care of animals on a farm. • Conducted epidemiological investigations and preventive vaccination companions.

Doctor'S Degree Veterinary, Médecine Vétérinaire

Treatment and surgery of livestock animals

Du In Methods And Practices In Health Economics Assessment, Health Economics, Faculté De Médecine - Université De Bordeaux

- Principles and methods of health economics evaluation - Use of clinical studies in the health economics evaluation.

Diu In Clinical Research Associate, Clinical Research

Master 1 In Public Health, Clinical/Medical Laboratory Science/Research And Allied Professions

Activities and Societies: - Clinical research and epidemiology - Probability and statistics applied in clinical research Recherche.