Accomplished senior-level, bilingual clinical research and operations director within the pharmaceutical industry. Expertise in leading international teams to execute complex clinical trials across diverse geographies including the United States, Latin America, Europe, and global markets. Demonstrated success in establishing and managing robust business processes, ensuring compliance with Good Clinical Practices, and navigating regulatory environments. Proven ability to develop and nurture strategic partnerships with pharmaceutical companies, research organizations, and healthcare institutions worldwide.
Work History
Associate Director, Study Lead Country Operations
AstraZeneca Alexion Rare Diseases
06.2021 - Current
Met and exceeded all Short- and Long-Term Incentive targets, increasing the personnel AstraZeneca-Alexion global career level annually.
Liaison between Country Operations Management and the Global Study Team, acting as the central point of contact for the team and clinical operations to improve overall team efficiency by streamlining project management processes and implementing new collaboration tools across studies.
Standardization of study conduct and clinical monitoring processes across studies.
Collection of site nominations and communications thereof to the clinical project lead.
Manage cross-functional, diverse teams for multiple large-scale projects, successfully completing each on time and within budget constraints.
Subject Matter Expert for Sponsor Inspections by Regulatory Agencies or during audits and quality metrics to provide solutions for continuous improvement
Special Projects: Project Manager: Project Maximize-Ambition 2030 Workstream for Health Equity; Lead: Clinical Trial Diversity Clinical Operations Management Workstream; Liaison: AZ Clinical Trial Diversity Team (Bridge Between Alexion and AZ); Happy Day Pills Group; Clinical Trial Diversity Action Plan; STAR-Patient Value Incubator-Bio Samples Enterprise Summit Planning Group
Director, Clinical Research Office
Ponce Health Sciences University
08.2018 - 06.2021
Founder and Director of the first Clinical Research Office within the Institute and in southern Puerto Rico tasked with integrating clinical trials into affiliated hospitals and independent Physician offices (~21 sponsored studies in first two years).
Developed a five-year business strategy to roll-out initiatives aimed at improving patient safety, quality of care, and outcomes (~$5 million in first two years).
Developed new clinical trials sites and maintained relationships with pharmaceutical companies, research organizations, affiliated hospitals, and independent Investigators for clinical trials (~170 new studies).
Developed and maintained relationships with Moffitt Cancer Center (Tampa, FL) to enhance the National Institute of Health U54 oncology program.
Developed and managed all Clinical Research Office staff, contracts, and budgets.
Director of Operations and Business Development
Puerto Rico Consortium for Clinical Investigation (PRCCI)
05.2016 - 08.2018
Recruited a team to develop and establish customer-centric collaborations increasing visibility of Pharma in Puerto Rico (35 new Pharma accounts in two years).
Promoted clinical trials opportunities throughout Puerto Rico with a centralized business model (~31 new sites).
Executed ~$4 million in income revenues and new contract development.
Supported clinical trials activities and revamped Pharma/Clinical Research Offices business strategies to maximize growth of public/private partnerships (~315 new studies).
Developed and executed site training and certification requirements related to Good Clinical Practices (first Yale University clinical research training Puerto Rico).
Director, Clinical Operations
TRS, LLC
09.2013 - 05.2016
Developed collaborations in the U.S. and Latin America (Argentina, Brazil, Peru, and Bolivia) to increase visibility of Pharma and clinical trials for TAMIR Pharmaceuticals (~$7.3 million in revenue).
Developed a business model for increasing research sites and site participation in clinical trials in 15 sites in Europe, Puerto Rico, and the U.S. (~15 Sponsored studies).
Provided customized, international operational strategies and coordination of studies across site locations.
Managed and executed contract budgets, customs, and foreign relations between international communications and banking systems.
Clinical Research Coordinator
University of Texas Southwestern Medical Center
11.2013 - 03.2015
Coordinated multiple Pharma/University led clinical studies for a Phase I oncology clinic.
Managed the overall design and conduct of ~six (6) Phase I oncology studies annually.
Assisted in the development and operationalized regulatory requirements of the first Phase I Oncology Clinic at the University of Texas Southwestern.
Conducted Informed Consents and patient/family education and training on study protocols and study participation.
Managed daily communication and data input with Pharma/University clinical trial monitors and onsite physicians and research investigators.
Operations Manager/Project Manager
DAC Patient Recruitment Services
03.2012 - 11.2013
Clinical Research Coordinator
Children's Medical Center
05.2006 - 03.2012
Clinical Research Coordinator /Data Manager
University Of Texas Southwestern Medical Center
06.2004 - 05.2006
Education
Doctor of Health Administration - Health Administration
University of Phoenix
Dallas, Texas
Master of Arts - Organizational Management
University of Phoenix
Phoenix, AZ
Bachelor of Science - Psychology
Pontifical Catholic University of Puerto Rico
Ponce, PR
Certification
Alexion Excellence Award - Clinical Trial Diversity, Inclusion, and Belonging
AztraZeneca One Team Outstanding Collaboration & Dedication Award (Dec 2023)
Alexion Living the Values Award (2022)
Clinical Research Coordinator - Barnette Clinical Research Certification
Six Sigma Lean Professional & Change Management Specialist - Management and Strategy Institute
Medical Interpretation - Texas Association of Health Interpreters
Leading People 2022 - AstraZeneca
Skills
Project Management
Operations Management
Diversity and Inclusion Initiatives
Strategic, Global Team Leadership
Database Management
Budget Management
Process Improvement
Analytical, Solutions-based Thinking
Regulatory Compliance
Timeline
Associate Director, Study Lead Country Operations
AstraZeneca Alexion Rare Diseases
06.2021 - Current
Director, Clinical Research Office
Ponce Health Sciences University
08.2018 - 06.2021
Director of Operations and Business Development
Puerto Rico Consortium for Clinical Investigation (PRCCI)
05.2016 - 08.2018
Clinical Research Coordinator
University of Texas Southwestern Medical Center
11.2013 - 03.2015
Director, Clinical Operations
TRS, LLC
09.2013 - 05.2016
Operations Manager/Project Manager
DAC Patient Recruitment Services
03.2012 - 11.2013
Clinical Research Coordinator
Children's Medical Center
05.2006 - 03.2012
Clinical Research Coordinator /Data Manager
University Of Texas Southwestern Medical Center
06.2004 - 05.2006
Doctor of Health Administration - Health Administration
University of Phoenix
Master of Arts - Organizational Management
University of Phoenix
Bachelor of Science - Psychology
Pontifical Catholic University of Puerto Rico
Alexion Excellence Award - Clinical Trial Diversity, Inclusion, and Belonging
AztraZeneca One Team Outstanding Collaboration & Dedication Award (Dec 2023)
Alexion Living the Values Award (2022)
Clinical Research Coordinator - Barnette Clinical Research Certification
Six Sigma Lean Professional & Change Management Specialist - Management and Strategy Institute
Medical Interpretation - Texas Association of Health Interpreters
Leading People 2022 - Degreed AstraZeneca
Overview
20
20
years of professional experience
1
1
Certificate
Hobbies
2X Ironman, Avid Traveler, and RV Camping Aficionado: Exercise, traveling, and enjoying nature provides me with work-life balance necessary for high-demand work environments.
Similar Profiles
Preeta CarolinePreeta Caroline
Senior Document Coordinator (Permanent - Remote) at Alexion AstraZeneca Rare Diseases (Payroll Of Atidan Technologies Pvt. Ltd.)Senior Document Coordinator (Permanent - Remote) at Alexion AstraZeneca Rare Diseases (Payroll Of Atidan Technologies Pvt. Ltd.)
Director, Strategic Accounts at Alexion Pharmaceuticals, AZ Rare Diseases UnitDirector, Strategic Accounts at Alexion Pharmaceuticals, AZ Rare Diseases Unit