Medical Science Liaison ( MSL ) Master
September 2016 --- April 2017
Senior Clinical Research Associate (CRA)
June 2014 --- June 2016
Perform either on-site or remote site visits and monitoring activities in accordance with protocol and GCP guidelines. Assess and ensure overall integrity of study and adherence to guidelines, protocols, and regulations. Interpret data to identify major risks to data integrity or any protocol deviations and make appropriate recommendations. Use expertise and judgement to identify and resolve complex site issues and deficiencies. Understand project scope, budgets, and timelines and manage project objectives to meet timelines. Participate in the identification and selection of investigators and clinical sites. Assist in the development of study procedures and guidelines. Interact with representatives of the Sponsor. Mentor junior staff on training, guidelines, and processes. Therapeutic Areas (diseases): Neurology (Multiple Sclerosis), Cardiology (Pulmonary Arterial Hypertension).
Clinical Research Associate (CRA)
February 2007 --- May 2014
Conduct on-site Visits (Pre-Study, Initiation, Monitoring and Close-Out)and prepare accurate and timely trip reports. Site management responsibilities. Undertake feasibility work and recruitment of potential investigators. Prepare Ethic Committees submissions and notifications to regulatory authorities. Negotiate contracts and study budget with sites. Assist with training, mentoring, and development of new employees. Support the project management team with clinical trial activities as required. Act as a Local Project Coordinator with the sponsor, investigational sites and study vendors. Therapeutic Areas (diseases): Cardiology (Acute Coronary Syndrome, Hypercholesterolemia), Ophthalmology (Diabetic Macular Edema), Oncology (Liver Cancer, Multiple Myeloma), Urology (Hyperactive Bladder), Infective (Influenza), Nephrology (Dialysis).
Owner of a retail shop
September 2003 --- January 2007
Chief of Quality Assurance
November 2000 --- August 2003
Responsible for the Quality Team working performance. Responsible for the company GMP training program. Conduct Internal Audits. Technical representative of the company in audits and inspections.
Inspector - Departamento Inspecciones I.NA.ME.
April 1997 --- November 2000
Inspect several types of companies with health-related activities to verify GMP and national regulations.
Chief of Quality Control
January 1997 --- March 1997
Validate analytical and microbiological quality control methods. Technical representative of the company.
March 1990 --- March 1997
Assist in medicines dispensation, prescripted compound forms preparation and commercial activities.
CollaborationDiligenceFlexibilityInnovative thinkingInterest in knowledgeOptimismProactivityProblem solvingResponsibilityStrategic thinkingWillingness to compromise
Skills and Expertise
Analytical skills Build and manage the Trial Master File (TMF) Create SOPs Guide students Interact with nurses Interact with physicians Monitor a clinical study Search literature on clinical trialsAct as the main line of communication between the sponsor and the investigatorAdminister, maintain and co-ordinate the logistical aspects of clinical trialsApprove patient informationAssess quality process issuesAssess site feasibilityAssess subject safetyAttend investigator meetingAssist with site trainingCoach clinical staff
Medical Science Liaison (MSL) Master in Pharmaceutical Industry from Talento Farmacéutico in 2017
Pharmacy Degree in from Universidad de Buenos Aires in 1997