professional with wide and in-depth experience in Pharmaceutical and Healthcare industry in activities ranging from project operations to process improvement. he had participated in cross-functional and cross-regional projects within Clinical operations, Project Management, Business Development, Quality Assurance and Laboratory. he can work either as part of a team or as a standalone contributor, always leveraging technology and systems usage. he had successful contact with customers to determine the best path for project delivery. he has managed direct reports and virtual teams in matrix structures, selecting, Training and motivating people: always leading by example. he has been involved in many starts- up processes and projects, encompassing activities such as data acquisition, technology transference, SOP creation, Compliance follow- up and anti-bribery policies. he is analytical, results and client oriented, proactive with excellent Negotiation and Communication Skills.
Director, Operations and Planning
Since October 2014
Associate Director, Global Strategic Site IntelligenceJanuary 2013 --- July 2013
• contribute to continual process improvement for efficient selection of investigative sites that provide quality data and sufficient patient populations. • ensure effective utilization of available data including Investigator database, performance history, and other applicable resources • develop, implement, and provide appropriate staff Training programs to meet business needs and continued professional development of staff. • provide proposal management with input on proposals. • interact with integrated site services, site monitoring, therapeutic delivery unit. • manage the quality of work through regular product review and metrics. • lead process improvement efforts and provide quality data and performance indicators trough internal and external Research to support proposal management
Associate Director Feasibility & Site ID. Regional HeadAugust 2010 --- December 2012
• manage staff in accordance with organization's policies and applicable regulations. responsibilities include Planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing Employee relations issues, and resolving problems. • participate in the selection and on-boarding process for new staff by conducting candidate review and participating in the interviewing process. • conduct on-boarding and Training for new staff in conjunction with departmental, Human Resources, and learning and development programs. • contribute to continual process improvement for efficient selection of investigative sites that provide quality data and sufficient patient populations. • ensure effective utilization of available data inclusive of Investigator database, performance history, and other applicable resources at regional level. • ensure that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by departmental management. • plan and schedule work within the department to ensure cohesive, effective management of resources. • develop, implement, and provide appropriate staff Training programs to meet the needs of the business and continued professional development of staff. • provide proposal management with input on proposals and budget development for feasibility and site identification components for projects. • interact with Clinical operations, Project Management, and access to patients. • lead the efficient selection of investigative sites, including rare diseases and expanding the acceptance of the bio-similar market. • conduct process improvement efforts and provide quality data and performance indicators trough internal and external Research to support proposal management and budget creation.
Process OptimizationJanuary 2007 --- July 2010
• creation of metrics for latin america aligned with global corporate standards and definitions • quintiles resource and portfolio management subject mater Expert for latin america • provide analytical support and Data Mining for quality processes, in order to achieve or surpass metrics in all areas of the business, including project and staff performance. • lead Research interviews to subject matter experts and Data Analysis that resulted in the implementation of global changes related to source data Verification, triggered monitoring, Phase I project process improvements and metrics development. • contribute to systems´improvements (sdlc)(uat, csv, vendor selection). • conduct quantitative and qualitative analysis of areas identified for change, evaluating data from internal systems and subject matter experts. • create a Process Optimization environment, settling metrics aligned with global standards and definitions: regional representative for enterprise transformation global team.
Laboratory OperationsSeptember 2004 --- December 2006
• supervise specimen management activities (room- temperature and frozen specimens), • perform shipments following iata/icao procedures and conventions. • primary point of contact for Clinical Investigator sites, answering and solving issues for study coordinators concerning Laboratory services. • perform LIMS (Laboratory information management system) Data entry and query solving.
Medical Technologist ( Microbiology)December 2000 --- September 2004
i have elaborated sops and work instructions according to ISO 9001-2000 and glp for cap accreditation. i had designed and implemented a centralized culture media Manufacturing process .the resulted was an increased productivity, while keeping gcp standards and nccls guidelines. i managed to decrease costs using a Forecasting method to determine raw materials ´budget i also settled the process for the Quality Control, tracking and Logistics of culture media.
Medical Techonlogist ( Microbiology)April 2000 --- September 2004
i coordinated technical activities for trial implementation, reporting and results delivery i performed specimen management for Clinical trials including laminar flow chamber and standard Microbiology sterile areas. i made several collaborations in protocols implementation and their Scientific Communications, including materials preparation for classes and congress meetings (isham) i helped in the set up of Analysis using molecular biology techniques i was able to help on the optimization and creation of new culture media for specific fungus Analysis
Medical Technologist ( Microbiology)September 1991 --- December 2000
i coordinated technical activities for trial implementation, reporting and results delivery. in direct contact with patients, i performed specimen receipt / extraction, specimen handling, processing and tracking. i performed Quality Control Analysis and interpretation according to gcp standards and nccls guidelines. i provided Training and Coaching of Laboratory staff in reagent preparation, Troubleshooting and maintenance with Laboratory equipment and instrumentation i kept Laboratory safety and infection control procedures, including standard precautions and hazardous chemical handling i performed technical job in protocols/Scientific Communications, including Statistical work on Epidemiology, improving my knowledge on medical and scientific terminology
Skills and Expertise
Analytical skills Analyze data Create SOPs Guide students Interact with physicians Interpret data Use content management systemsAct as the main line of communication between the sponsor and the investigatorAdjust processes Administer logisticsAdminister supply requestAdvise on strategyAseptic techniquesAssess site feasibilityassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Assign activitiesCoach and provide guidance to clinical staff.Communicate effectively on different company levelsCommunicate with investigatorCommunicate with sponsorCoordinate projectsCoordinate logisticsCreate standard operating procedure (SOP)Data entryData miningData validationData verificationDevelop study metricsDevelop study timelinesDevelop strong internal relationships with stakeholdersDirect co-workersDirect co-workers to achieve resultEnsure data consistencyEnsure data integrityEnsure good clinical practice (GCP)Establish professional relationships with partnersFollow-up of Quality Management System (QMS) processesInteract with CROsInteract with computer specialistsInterpret analytical resultsInterpret dataLiaise with professionals in other divisions of the company as requiredShipment of biological specimenSpecimen processingUpdate Clinical Trials Management System (CTMS) Work cross-functionallyWork collaboratively with the other members of the clinical research team Work under specific instructions
Bsc in Chemistry and Biotechnology in Molecular Genetics from ORT Technology Institute in 2004
Health and Biology Related Sciences in Biology, Biochemistry, Medicine from University of Buenos Aires in 1999
High School in Bachelor from Manuel Belgrano Institute in 1985
Training and Certification
Expert GCP for Managers and Staff Interacting with Investigational Sites in 0000 Certification