Project Management Clinical Research

Gabriel Basagoitia

Miami, FL • 305-***-**** • *****************@*****.***

LinkedIn.com/in/gabriel-basagoitia-mbee-ssgb-9133766b

PROJECT MANAGEMENT LEADER

Astute, accomplished, and results-oriented lead project management professional focused on project execution, coordination, and oversight from project inception to final outcome across organizational process, clinical trial, and operational support endeavors. Recognized for implementing and leading change, team development and performance, creating novel tools and processes to identify and measure key performance indicators, and improving overall organizational performance.

EDUCATION AND CERTIFICATIONS

Master of Science in Biotechnology Entrepreneurship and Enterprise GPA: 3.9/4

Johns Hopkins University, Baltimore, MD

Bachelor of Science in Biochemistry GPA: 3.5/4

Bachelor of Arts in Interdisciplinary Studies GPA: 3.5/4

Florida International University, Miami, FL

CERTIFICATIONS AND AFFILIATIONS

Certified Associate in Project Management (CAPM), Project Management Institute

Six Sigma Green Belt, Council of Six Sigma Certifications

Design and Interpretation of Clinical Trials, Johns Hopkins University

Good Clinical Practice, National Institute of Drug Abuse

Apple Certified Mac Technician, Mac OS

Apple Certified iOS Technician

Languages

English - Native

Spanish - Advanced

Portuguese (Brazil) -Basic

EXPERIENCE HIGHLIGHTS PROJECT MANGEMENT, TECHNOLOGY, AND CLINICAL RESEARCH

Biorasi, Aventura, FL, Jun 2019 - present

Lead Project Manager, Clinical Trial Process and Technology

Optimize clinical trial project performance and implement change management processes in alignment with the Chief Information Officer and Vice President for Process and Technology by developing project plans, providing leadership to cross-functional teams across multiple geographies, tracking performance, and resolving issues. Improved customer satisfaction by 20% after implementing project management process and system improvements.

Created and led a work breakdown structure (WBS) that instigated the development of a formal Project Management Office for the entire organization

Implemented use of Six Sigma techniques to build a lean multiple process for the company

Introduced a new change management process to build responsive culture and drive faster project turnaround, incorporating Microsoft Project, workflows, deal review, and sales-to-delivery hand off

Lead $300,000+ budget development and administration, vendor qualification, and team member training, defining clear roles and responsibilities to ensure efficient and successful project completion

Oversee complete project lifecycle, monitoring project health and advising executive leadership on project plans, timelines, and milestones

Ensure documentation compliance with local, state and federal regulatory guidelines, requirements, laws and research protocols

Apple, Inc., Miami, FL, Oct 2013 – Jun 2019

Lead - Assistant Manager Aug 2017- Jun 2019

Lead Genius – Jan 2017 – Aug 2017

Genius – Jan 2016 – Jan 2017

Sales Expert – Oct 2013 – Jan 2016

Promoted, sold, and serviced Apple products, engaging clients and associates and achieving customer satisfaction and employee retention. Performed basic troubleshooting procedures on iOS devices and MAC OS Computers. Responsible for overall store operations, sales performance, and scheduling and general management for 200 store staff members.

Built and led high performing sales teams that consistently met or exceeded sales and customer service performance standard, improving year over year results by 15% in most categories

Originated sales report that outlined individual staff member performance versus store and company goals through the use of Business Analytics techniques

Directed opening of five new stores in market and trained over 1,000 staff members to meet company sales and service standards

Florida International University Miami, FL, 2015 - 2018

Undergraduate Researcher – Aptamer and Biosensors – 2015

Chemistry Lab Teaching Assistant – 2015

Performed, studied, researched, and reported on multiple different aptamers developed through the use of SELEX. Performed advanced procedures complex laboratory equipment needed to understand the DNA strand and its affinity to a selected target analyte. Responsible for student lab lectures, their safety, and understanding of chemistry courses at FIU.

Part of a high performing research lab that identified aptamers that identify femtomolar amounts of cocaine in saliva

Supported the lab in making their processes more efficient and less costly to produce the same or better results from testing

Lead chemistry lab courses for entry chemistry students

CLINICAL RESEARCH

1.Trial Master File support of a Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL2 in Patients with Paroxysmal Nocturnal Haemoglobinuria (PNH) 2019

2.Phase II, An Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of APL2 in the Treatment of Post-Transplant Recurrence of C3G or IC-MPGN 2019.

3.Global site feasibility assessment of a Multicenter, Single-Arm, Study of the Efficacy of (DEVICE UNDER TESTING), on Samples Collected Using (DEVICE UNDER TESTING), Versus Esophagogastroduodenoscopy, for the Diagnosis of Barrett’s Esophagus in an At-Risk Screening Population 2019 (Global Site Feasibility Assessment for Study Comparing a Non-Evasive Cell Collection Device Versus Esophagogastroduodenoscopy for Diagnosis of Barrett’s Esophagus).

4. Global site feasibility assessment of a Multicenter Case-Control Study of the Efficacy of (DEVICE UNDER TESTING) on Samples Collected Using (DEVICE UNDER TESTING), Versus Esophagogastroduodenoscopy, for the Diagnosis of Barrett’s Esophagus with and without Dysplasia, and for Esophageal Adenocarcinoma 2019.

5. Phase III, Randomized, Multicenter, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of APL2 in Subjects with C3G or IC-MPGN 2019.

6.Phase IV, Multicenter, Clinical Performance Evaluation of ACTIFUSE SHAPE in Spine Surgery

7.Phase II, Randomized, Double-Blind, Vehicle Controlled Study of the Efficacy, Safety, and Tolerability of (DRUG UNDER TESTING) Topical Spray for the Treatment of Pruritus in Adults with a History of Atopic Dermatitis.

8.Phase III, Safety and Efficacy of (DRUG UNDER TESTING) Delayed Release 400 mg Tablets in Patients with Moderate-to-Severe Papulopustular Rosacea and Positive Lactulose Breath Test. A Multicenter Double-Blind, Placebo-Controlled Randomized Clinical Trial

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