Fabiola Vanessa Aldana Sanchez

Trial management of national and international clinical studies and trial team coordination, status updates to management, prepares trial core document, setup and maintenance of the Trial Master File, submissions of all required trial applications to CA and EC/IRB, organizes and conducts investigator meetings, supports the process of country and site selection, contracts with vendors and CRO Management, co-Monitoring, prepares SOPs, conduct and follow-up of GCP audits and GCP inspections

Perform assessments, pre-trial site assessment visits, site initiation and start-up, site monitoring, site management and study close-out activities, Recruitment strategies as well as contingency planning, study supplies are adequate, assure accuracy, validity and completeness of data, completion of protocol documents, QA is completed for the CAPA Plans, Protocol documentation and submission to protocol approvals, Protocol Budget, Payment and Costs, Teamwork with stakeholders, CRA trainer

Protocol Manager of Hepatitis Diabetes, Oncology and Cardiovascular Phase II and III studies Coordinator of the quality improvement program CAPA Plan coordination and support in international audits Direct work with central team in USA and collaboration with Site Managers worldwide Teamwork with Data Managers and CTA´s Experience in Protocol start up, follow up and closure and documentation and submission for approval to regulatory agencies Budget approval, assignation and administration.

Documentation submission for approval to regulatory agencies Data base assistance to Data Managers Teamwork with Site Managers and Monitors

Planning and execution of medical basics trainings for sales representatives Develop of integration courses, performance evaluation programs and communication improvement techniques Instructor in Advanced Sales Techniques trainings

International Master focused on Strategic Management, Leadership, Multicultural Diversity and Economy, Finance, Accountability and Project Development in a international environment

Project Management Diploma

GCP, ICH, Clinical Research Projects, FDA

BA on Organizational Psychology Professional experience modality

BA on Medical Surgeon- Career truncated