Biography:
Over ten years of experience as Clinical Operation Director in Clinical Trials and Regulatory affairs for the pharmaceutical industry and CRO business. Analytical and resourceful professional, who has led internal and stakeholder teams to develop and implement solutions for: operational, regulatory, medical affairs in the private industry, academy and government sector.
Experience:
AVANZAR. Colombian scientific society for Clinical Research. Jan 2012- up to date
President
LATAM CLINICAL TRIALS INC Apr.2005 – up to date
President and Chief Executive Officer 2008 – up to date
• Led the company to breakeven point in one year.
• Reached sales over $3M US and 40% of profitability
• Expanded markets in Latin America, Central America and Caribbean
• Created a network with regulatory authorities over LA
Director of Clinical Operations 2005 -2008
• Cofounder and designer of corporate business model
• Implemented standard operation procedures for clinical trials management, regulatory submissions for pre and post marketing products, training and continues education.
• Managed, recruited, coached and led a team of more than 60 health professionals in research area.
PFIZER. Bogotá-Colombia Nov. 2001 – Ag. 2004
Clinical Research Manager (CELA Region)
• Oversight the submission of pre and post marketing products as well as clinical trials for Colombia, Ecuador, Peru, Venezuela, Central America and Caribbean.
• Managed, recruited, coached and led research team of more than 5 countries in Latin America.
Wyeth. Bogota-Colombia 2001
External Advisor
• Managed, conducted, monitored and controlled quality assurance of Clinical Trials and regulatory submission in LA.
Merck Research Lab Feb 1998 – Apr. 2001
CRA and Local reprints coordinator
Hospital practice and family physician at Public Sector Jan 1990 – Sept