Hany Robin

Resourceful professional in management operations known for high productivity and efficient task completion. Possess specialized skills in strategic planning, team leadership, and operational improvement. Excel in communication, problem-solving, and adaptability, ensuring seamless execution of business strategies and enhancement of team performance.

• Member of Egyptian Syndicate of Medical Doctors
• Professional Medical License

Kingdom of Saudi Arabia (KSA), Ministry of Health Kingdom of Saudi Arabia; International Pharmaceuticals in KSA, Project Manager, 09/2020, 09/2023

PDC MENA, UAE-Dubai, Regional Clinical Project Manager (MENA), 05/2018, 09/2022, Essentially serving as liaison between study Sponsor, investigational sites and the contract research organization, ensuring studies are completed on time, within the budget, as per the scope agreed upon with the Sponsors, according to the study protocol and the quality standards set forth by the local ethics and regulatory requirements, company & Sponsor’s standards and procedures and as per ICH- GCP. Using the metrics tools to ensure study is running per timelines, within the budget, and as per the scope (e.g., DM Query Trends, Missing CRF pages, Outstanding Monitoring Reports, FTE Resource allocation, Study Progress Report, Monthly CRA Visit Planner, etc.). Updates the Study Progress Report and Monthly Visit Planner on a monthly basis and posts them on BOX. Updates action items in the Study Progress Report on a weekly or bi-weekly basis depending on phase of the study and as per agreement with Head of Clinical Operations (HCO) as applicable. Attends regular calls with (HCO) to provide updates and discuss issues for which action is required. Leading on the creation and maintenance of all study files, including the study master file, and oversight of site files on CTMS. Conducts regular meetings with team members to follow-up on progress and discuss issues for which action is required. Supervises and assesses the performance of team members and provides feedback to Country Manager for appraisal every 6 months. Escalates all relevant issues to the HCO and the GM where the study is conducted. Ensures CRAs’ compliance with the study monitoring plan and with all the assigned tasks. Ensures implementation of the project specific training programs and materials for the team and tracks training documentation and Should be well informed of regulatory changes and communicates the latter to team and Sponsor. Proactively identifies and prevents issues related to the clinical portion of the study, including study processes, monitoring or site issues. Reviews monitoring visit reports and ensures adherence to study timelines for report submission and finalization. Follows the payment of investigator’s fees in collaboration with the CRA. Manages the feasibility studies in one or several countries in collaboration with CRA team to select the most appropriate research locations. Conduct selection, initiation and co-monitoring visits with the CRA. Ensures all study documents are uploaded on BOX on regular basis according to relevant SOPs. Managing Regulatory processes following Local guidelines for Clinical trials submissions. Management of Clinical Operations outsourced candidates internally and externally in KSA and Egypt. Arranging project specific study Management plans including Risk management, Communication plans according to contracted services scope. Training management for outsourced candidates. Follow up with clients on outsourced employee assessments and reviewing KPIs. Managing Financial and budgetary project aspects.

• Triclinium Clinical Development Middle east & North Africa CRO - TCD MENA (SAE), Cairo, Egypt, Clinical Project Manager (MENA), 11/2016, 04/2018
• ClinServ International SARL, Clingroup holding (HQ: KSA/Lebanon) CRO - MENA, Cairo, Egypt, Clinical Project Manager (MENA), 04/2013, 10/2016

• ClinServ International SARL, Clingroup holding (HQ: KSA/Lebanon) CRO - MENA, Cairo, Egypt, Senior Clinical Research Associate (MENA), 04/2010, 04/2013
• ClinTec International (HQ: Glasgow-Scotland) CRO, Egypt, Senior Clinical Research Associate, 09/2009, 04/2010
• Sanofi- Aventis Pharmaceuticals, Cairo, Egypt, Clinical Research Associate (CRA), 11/2006, 09/2009

Hospital Management Specialist, Sadat Academy for Management Sciences /MDA, 05/2023, 07/2024

• Macintosh Apple Systems
• Microsoft Windows 10 Systems
• Microsoft Office (MS Excel, MS Word, MS Outlook, MS PowerPoint)
• Oracle systems
• EDC Platforms (Oracle, Medidata Rave, Clincapture, Icotrial, Oracle, Veeva, Openclinica)
• CTMS (IcoTrial, Veeva, Oracle)

MEA, Regional and International Pharmaceuticals - MEA, Egypt, Phase III, Anti-infective drug study, Site Manager, Ghana, Phase III, Anti-infective drug study, Site Manager, Tanzania, Phase III, Anti-infective drug study, Site Manager, UAE, Phase II, Anti-infective drug study, Site Manager, KSA, Phase II, Anti-infective drug study, Site Manager

• Passport Number: A29770936
• Date of Birth: 01/11/1981
• Gender: Male
• Nationality: Egyptian
• Driving License: Valid (International Driving License)
• Marital Status: Married

• Arabic
• English
• French

References are furnished upon request

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