Contract - Orando, Florida since Oct 2011
Clinical Research Site Manager
Covidien Oct 2010 - Apr 2011
CORE TEAM MEMBER/SME/PROJECT ADVANCE
Covidien Positive Results for Life Dec 2009 - Apr 2011
SR CLINICAL TRIAL MANAGER
Genentech Sep 2007 - Mar 2010
Senior Clinical Trial Manager
Inclinix, Inc. 2007 - Jul 2007
Sr. Project Manager
Education:
Universidad de Puerto Rico 1981 - 1986
BS, Natural Sciences, Biology, Chemistry & Pre-Med
University of Puerto Rico 1981 - 1986
Bachelor in Sciences, Biology/Chemistry
I am relocating to Orlando, FL with arrival date August 1, 2011. I am a dynamic, highly qualified, effective, and results driven professional seeking a challenging position that will maximize my wealth of skills and talents, specifically addressing the complexities of Clinical Operations and Clinical Research Management in the pharmaceutical or biotechnology industry setting. I also bring fifteen years experience in clinical research, along with monitoring in Latin America, ten years experience in Project Management of clinical trials including national and global, from Phase I to Phase IV.
Honor & Awards:
1996, Alzheimer’s Association, Tampa, FL Chapter
Memory Walk 1996: Nelson Melendez, Captain – Largest Corporate Team, Somerset Pharmaceuticals, Inc.
1999, TAP Pharmaceuticals, Inc.
American Music Awards Journey – Reward given to five selected of several nominated by Development Management to accompany the Sales Team Group as a reward for Excellence in Clinical Research and Project Management. Rewarded for Data Management and Query Resolution Initiative, reducing query issues by 38% and increasing data entry and data base close-out by 80 days.
2009, CBI's 3rd Annual Oncology Clinical Trial Summit
Participated as a guest Speaker at the “CBI's 3rd Annual Oncology Clinical Trial Summit” September 14-15, 2009, in Bethesda, MD. The subject of the presentation was “Enrollment and Protocol Compliance in follow-up phase: Major Clinical Operation challenges during the conduct of clinical trials”.
Pra Health Sciences
Country Lead Monitor, Oncology-Pharmaceutials
Orlando Health Jan 2017 - Jun 2017
Manager, Clinical Trials Coordination  Pediatric Oncology Program
Inventiv Health Clinical Mar 2016 - Dec 2016
Senior Project Manager
Kempharm, Inc. Jun 2014 - Feb 2016
Senior Director Clinical Trial Management
Inc Research May 2013 - Jun 2014
Project Manager Ii
Education:
University of Puerto Rico 1987
Bachelors, Bachelor of Science
University of Puerto Rico - Cayey 1981 - 1986
Master of Education, Masters, Bachelors, Bachelor of Science, Biology, Chemistry
Skills:
Clinical Trials Cro Ctms Protocol Clinical Data Management Pharmaceutical Industry Clinical Monitoring Fda Clinical Research Project Management Clinical Operations 21 Cfr Part 11 Neurology Oracle Clinical Sop Gcp Software Documentation Remote Monitoring Oncology Clinical Trial Management Research Project Management Remote Management Remote Infrastructure Management
Interests:
From Phase I To Phase Iv I Am A Dynamic Highly Qualified Along With Monitoring In Latin America Effective