Michael Nabil Email & Phone Number

Cairo, Egypt

Egypt

Egypt

Novartis

Egypt

Accountable for planning, executing and reporting on a number of clinical studies for assigned countries, from planning and site feasibility through study close-out, in compliance with Novartis processes and regulatory requirements.This position is key to good communication and professional relationships with clinical investigators and international/local colleagues in HQs and CPOs as well as regulatory authorities at those countries.

 Responsible for conducting and Monitoring Global Clinical Trials in Egypt:o Feasibility and selection for study sites in Egypt.o Assure continual GCP, ICH and SOPs compliance.o Review & Monitor the progress of the projects and being the link of communication and the protocol application between the global team in the headquarters and Novartis Egypt.o Secure the final quality of data generated from the Egyptian sites to secure the Global file submitted for FDA approval.  Responsible for the following activities during the course of clinical projects:o Feasibility and selection for study sites in Egypt (Phase III, Phase IV, IIT, Regional & PMS studies).o Plan Project Timeliness & Budget allocation.o Proactive planning for expected challenges and actions needed to overcome.o Train all study participants.o Assure continual GCP, ICH and SOPs compliance.o Closely monitor the protocol application in Egypt to match the European & Global directives.o Interview and select the proper candidates such as study coordinators for global projects. Cross functional cooperation (Marketing & Sales) Conduct training courses & Investigator Meetings:o Responsible for providing different training courses in different Investigator Meetings that strengthen both their skills and knowledge for the Clinical research process.o Facilitate Training Course & Meetings content through demonstrating practical examples, using aids as audio visual aids/equipment/workshops/team buildings/practical exercise.o Handle all Meetings logistics.o EDC/Clinadmin Regional Super user.o Subject Matter Expert for trainings/system access.o TPA Trainer.o GTN (Global Training Network) Contact Person.

Responsible for Feasibility and selection for study sites in Egypt (Phase IV, Regional & PMS studies).Responsible for Project & Budget setting (up to 1 Mio EGP).Train & certify all study participants.Assure continual GCP, ICH and SOPs compliance.