Wael Khazen

• Coordinated clinical studies (feasibility study, methodology)

• Operational monitoring of projects, dashboards and monitoring of charts

• Managed of cross-functional teams and third-party vendors

• Coordinated setting up and logistical follow-up of the clinical studies

• Managed the budgets of the various clinical studies

• Prepared and delivered study-related updates, dashboards, and reports to study teams, and sponsors/vendors/partners

• Ensure regulatory submission in several countries

• Drafting and updating the different documents according to the MDR requirement (CER, PMS, CDP, IFU...)

• Designed and developed pre-clinical and clinical studies for a new medical device to obtain CE marking

• Initiate PMCF studies for different medical devices

• Medical referee for 3 medical devices (MD)

• Managed the translation of all company medical device IFUs into 22 languages

• Maintained study-related essential documents and ensured compliance with regulatory requirements

• Conducted medico-scientific of clinical studies in nutrition

• Feasibility study in collaboration with the different departments (Biostatistics, data management, legal department, scientists….)

• Selection and collaboration with CROs to carry out certain study tasks

• Estimation and management of the study budget

• Designed and developed protocols in the field of digital dietary assessment Tool

• Collaborated with clinical operational teams and the different departments to carry out the studies

• Collaborated effectively with internal and external stakeholders, communicated project status, escalated issues, and troubleshooted

• Publication of a scientific review (a viewpoint) (in publications list)

• Conducting bibliographic research to develop the scientific context and essential elements of a protocol

• Conducted medico-scientific and follow-up of clinical studies

• Communication with Key Opinion Leaders to develop the study design

• Designed and developed protocols and all the essential documents of a clinical study (ICF, e-CRF, reports…)

• Collaborated with clinical operational teams and followed the mandates of the regulatory authorities.

• Collected, analyzed and summarized clinical data for submission to regulatory agencies

• Responsible for oversight of identification and selection of investigator site

• Foretasted and budgeted for all projects and clinical studie

• Designed and developed protocols and amendments in clinical studies with quality and respect for procedures

• Conducted medico-scientific follow-up of clinical studies in dialectology

• Collaborated on medical-scientific reports of clinical study

• Managed various transversal processes of the clinical projects (BIC, regulatory process)

• Coordinated all clinical studies of the center: feasibility studies, methodologies, dashboards and chart monitoring, Initiate telemedicine studies

• Developed protocols, CRF, patient information notes and regulatory submissions (CPP, ANSM, CNIL)

• Designed and managed subject databases

• Conducted logistical follow-up of the clinical studies with the different representatives of the clinical research (the CROs, the investigator centers, the regulatory authorities, CRA)

• Managed the budgets of the various clinical studies

• Conducted training and ensured proper resource allocation for study teams

• Coordinated clinical studies (feasibility study, methodology),

• Operational monitoring of projects, dashboards and monitoring of charts

• Managed a team of CRA

• Coordinated logistical follow-up of the clinical studies

• Managed the budgets of the various clinical studies

• Designed and managed databases.

• Assumed overall responsibility for negotiation of development and management of various clinical trials

• Prepared, organized and developed specifications for clinical research and protocol tools.

• Wrote CRF (case report forms).

• Completed visits implementation, monitoring and closing centers.