Mohamad Cheaib Email and Phone Number

-Generate Business Plan: update, implement and monitor-Responsible of unit sales target-Sets-up plans and strategy (PMP, Sales and Marketing) including milestones in collaboration with BD Department-Maintaining high visibility through proper use and update of all marketing tools-Prepares/Validate Proposals including timelines, assumptions and secure profitability-Performs market/competitor intelligence-Get new potential clients/projects-Maximizing profitability in terms of: Volume of work, operations milestones and qualities, saving expenses-Responsible for the operational execution, allocation of resources (internal/external) for all projects within quality compliance, allocated budgets, timelines & approved task orders-Responsible of deliverables customers satisfaction-Establishes and implements Countries operational units’ MSA, JV, MOU, policies, procedures-Conducts external meetings with clients/partners/providers based on business need-Preparation of monthly invoices to clients in collaboration with Admin & Finance-Prepares the JD’s and PMDP’s of subordinates and following up the execution with each of them on monthly basis -Report on monthly basis to top management the overall activities status including amount invoiced per project /resources allocation and the corporate cost per employee/number of proposals submitted and the number of proposals awarded-Liaise with different providers required to ensure current and potential project requirements are fulfilled-Develop operational strategies for the improvement and evolvement of the department-Ensure the staff and department readiness for any system/project audit/inspection-Conduct periodic meetings with PMs and coordinators to ensure all project milestones are met-Review and approve project management plans before the start of each project-Manage overall home trial services for the assigned project-Control of equipment, supplies and retention items-Submit all needed study documentation

 Monitor the conduct of clinical trials, especially enrollment and quality of data in all phases (especially phase IV studies). Preparation and Submission of Health Authorities and IRB Packages Conduct Qualification, Initiation, Interim, and Closeout monitoring visits. Verify subject safety and site adherence to FDA Regulations and ICH/GCP Guidelines. Review CRF, Informed Consent Documents, and Queries Acquire specific clinical and therapeutic knowledge related to studies monitored. Ensure complete and thorough study of drug reconciliation. Manage trip reports, letters, query resolutions, and expenses. Review site master file contents and ensure its adherence to local regulations and ICH-GCP, 21 CFR Guidelines part 11. Provide support and timely follow-up for all audits. Ensure Adverse Events are reported appropriately, accurately, and in a timely manner and those follow-up activities are conducted as necessary. Preparation and Submission of samples export package to Health authorities and Customs

 Assist in the maintenance of an adequate stock and expiry date checking. Check each patient’s medication record every time Verifying instructions from physicians on the proper amounts of medication to give to patients Counsel and advice patients on prescription medications. Ensure that there is no drug-drug interaction on the patient profile. Overseeing the work of and mentoring pharmacy technicians Assist the manager in setting up the staff shifts

 Ensures that the submission package complies with the site and local regulations (protocols, investigator brochures, informed consents, subject information templates, etc.) and provides investigator regulatory feedback to the Country Manager (CM) Submits or assists CRAs/Lead CRAs/PMs in preparation of packages and submission of regulatory documents to the Central (IRB/EC/REC) on behalf of Sponsor and clinical sites. Prepares or assists in preparation of submission packages for import/export license of study drugs, biological samples follow- up till it is obtained. Assists clinical sites with submission to local (IRB/EC/REC); assists in the resolution of issues approval processes. Serves as a local regulatory contact for the clinical site staff to answer questions pertaining to Investigator regulatory documents.

 Ensuring quality, consistency, and accuracy in the conduct of clinical research trials and completion of case report forms. Boosting recruitment, screening potential patients and targeting specific study and enrolment goals. Maintaining accurate communication with study monitors, and related study personnel. Coordinating study procedures and activities with participating co-investigators regarding ongoing studies. Maintaining updated patient logs in study