Amy Gail Osborne, BSBM, MLT

Capistrano Beach, California, United States

ad489v@r.postjobfree.com 949-***-****

linkedin.com/in/amygailosborne

Summary

A possible summary is:

I have over 30 years of experience in the clinical and laboratory field, supporting healthcare organizations in conducting successful and compliant clinical studies. I hold an MBA degree with a focus on project management and healthcare management, and an MLT certification with laboratory skills. My field of expertise covers global pharma, companion diagnostics, and medical device companies, and a wide range of topics, such as COVID-19 testing, regenerative medicine, gene sequencing, and complex assays. As a clinical trial consultant, I leverage my extensive experience and knowledge to help healthcare organizations achieve their goals and deliver high-quality outcomes. In my previous role as a Program Manager at Quest Diagnostics, I collaborated with multiple internal and external stakeholders to facilitate hundreds of FDA submissions for clinical studies. I also implemented lean methodologies to improve enrollment, data quality, turnaround time, and customer satisfaction. My mission is to advance medical research and innovation with my clinical, scientific, and managerial expertise.

Experience

Project Management Consultant

Clinical Trials For All

Dec 2023 - Present (5 months)

Consultant-FDA, CAP, CLIA, Regulatory, Clinical Trials dessimnation and operational workflows with achieved turna-around-time through special handling resources already in place. Cost savings achievements

Project Manager Program Management Office

Quest Diagnostics

Feb 2023 - Oct 2023 (9 months)

FDA & Clinical Trial expertise help facilitate 510k, BLA submissions at hand Senior Manager

Quest Diagnostics

Dec 1994 - Oct 2023 (28 years 11 months)

Bio Analytical Manager IV

Genentech Roche

Mar 2021 - Feb 2023 (2 years)

Amy Gail Osborne, BSBM, MLT - page 1

Grew Clinical Trial Operations from 2k annually to 350k annually for ten solid years. Achieved this through Education, Recognition, committed TAT.

Manager Clinical Affairs & Mgr EHS

Applied BioCode, Inc.

Aug 2019 - Mar 2021 (1 year 8 months)

Scientific and Clinical oversight of Clinical Trial/Affairs KOLs

Consultations

Customer Insights Evals

Global Regulatory

Clinical SOPs, Clinical Worksheets & Templates

Regulatory Design and Changes

Clinical Project Manager

Liveyon LLC

Jan 2019 - Apr 2019 (4 months)

Provide, launch, author Clinical FDA submissions. IND, BLA and FDA applications. Managing responsibilities for all project related activities and Clinical Studies (Stem Cell Research). Client Operations Manager

Q2 Lab Solutions/Quest Diagnostics Joint Venture

Jan 2016 - Feb 2018 (2 years 2 months)

Collaborated with new teams. Took them all around the countries and taught them my business model for success

Site Operations Manager, Customer Liaison Manager, Clinical Trials Valencia/ SJC

Quest Diagnostics

Dec 1994 - Jan 2016 (21 years 2 months)

•Act as Liaison between Clinical Trials Nichols Valencia, Nichols Institute, SJC, UK, China organizations to ensure pharma/ IVD sponsors expectations are met. Sales and contract/Bid negotiation

•Monitor and ensure Sponsors timelines, commitments, and patient requirements are met within the 14 testing escoteric laboratories at the Nichols Institutes Several site visits and monitoring (CRO monitoring and qualifying) Manage and support Specimen Processing team whom accession and release patient samples to the various escoteric laboratories at the Nichols Institutes. Meanwhile, incorporating any “special handling” procedures set forth by our sponsors.

Collaborating team member, Lab Representative, MLT, Lab Manager, Client Service Representative, Problem Resolution expert, Project Manager, Sales Representative, and Study Manager. Liaise between Nichols Laboratories and Business Units to ensure smooth patient tracking and assay completion to minimize turn-around-time, for the study at hand. Coordinating with Medical Directors, Scientific Directors, and Scientific Affairs departments to ensure study continuity throughout sometimes complex protocols. Amy Gail Osborne, BSBM, MLT - page 2

Attend/Facilitate numerous review meetings covering patient/assay capacity, quality, and ongoing projects

•Involved in implementing and training/educating personnel on continuous improvement plans, GCLP, and CAP/CLIA standards.

Building and maintaining a working relationship with all 14 laboratories at Nichols Institute, SJC. Sales Reps, Scientific Directors, Scientists, Operations, Logistics, Suppliers Molecular Genetics- Technical Representative

Technical Representative

Jan 2008 - Jan 2009 (1 year 1 month)

Provided, assisted, advised, problem resolution regarding patient samples in the Molecular Genetics department pre-assay set-up. Working with Scientfic Directors, Medical Director, Genetic Councellors, and Laboratory Scientists in this regard.

Coagulation/Immuno-Chemistry Laboratory Associate I- Laboratory Associate II Laboratory Associate II

Jan 1999 - Jan 2006 (7 years 1 month)

Set up various technical and non technical assays

Prepared, arranged, and tested patients on various laboratory testing platforms implemented and tested test development with R&D

Specimen Management

Quest Diagnostics

1997 - 1999 (2 years)

prepared, arranged, alliquotted, delivered, and stored various patient samples throughout the Nichols Institute escoteric testing laboratories

Chemist

PAL Professional Animal Lab (ANTECH DGX)

1992 - 1997 (5 years)

Education

Southern New Hampshire University

Master of Business Administration - MBA, Project Management University of Phoenix

Bachelor of Science, Business Management

2000 - 2007

Newbridge Medical College

MLT, CPR, Phlebotomy, Medical Lab Tech

1990 - 1993

Amy Gail Osborne, BSBM, MLT - page 3

Newbridge Medical College

Diploma, MLT Iinternship -PAL Animal Labs-followed by Job as a Chemist (4 years) 1990 - 1993

MLT

Southern New Hampshire University

Master of Business Administration - MBA, Business, Management, Marketing, and Related Support Services, Marketing

Jan 2016 - Present

University of Phoenix

Bachelor of Science - BS, Business Administration and Management, General Jan 2000 - Present

Newbridge Medical College

MLT, CPR, EKG, Clinical Laboratory Science/Medical Technology/Technologist Jan 1997 - Present

Licenses & Certifications

MLT

EKG

CPR

solder

crimp connections/one touch solder - MDAC

lugs

hyper connections

GLP

GCLP

Amy Gail Osborne, BSBM, MLT - page 4

phlebotomy

Lean Six Sigma Black Belt (ICBB) - Quest Diagnostics Lean Six Sigma Green Belt (ICGB) - Quest Diagnostics Selling to Executives - LinkedIn

Communication Foundations - LinkedIn

Managing Organizational Change for Managers - LinkedIn How to Create a Life of Meaning and Purpose - LinkedIn NIAID Good Clinical Practices v2.0 - The National Institutes of Health Issued Feb 2021 - Expires Feb 2024

Top 10 Rules for Highly Effective Leadership - LinkedIn Strategies for Effective Leadership Teams - LinkedIn MDAC - McDonell Douglas Aircraft School of Long Beach Skills

Sales • Contract Negotiation • Drug Development • Operations Management • Customer Relationship Management (CRM) • Business Development • Electrical Wiring • Soldering • Crimping • CRO Management

Honors & Awards

Amy Osborne - Quest Diagnostics

Jan 2012

Lab Week Champion 3 years

Amy Gail Osborne, BSBM, MLT - page 5

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