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Case Number: A-20217-84837

Fiscal year: 2021

Fiscal Year

2021

Case Number

A-20217-84837

Case Status

Certified

Received Date

2020-10-09

Decision Date

2021-05-19

Refile

N

Original File Date

2021-01-01 09:24:51

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

EDWARDS LIFESCIENCES LLC

Employer Name Slug

edwards-lifesciences-llc

Employer Address 1

ONE EDWARDS WAY

Employer Address 2

Employer City

IRVINE

Employer City Slug

irvine

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

92614

Employer Phone

(949) 250-3444

Employer Number of Employees

14000

Employer Year Commenced Business

2000

NAICS Code

339112

FW Ownership Interest

N

Employer Contact Name

Tracie Pham

Employer Contact Address 1

ONE EDWARDS WAY

Employer Contact Address 2

Employer Contact City

IRVINE

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

92614

Employer Contact Phone

(949) 250-3444

Employer Contact Email

Tracie_Pham@edwards.com

Agent Attorney Name

Claudia P Martorell

Agent Attorney Firm Name

Larrabee Albi Coker LLP

Agent Attorney Phone

(858) 642-0420

Agent Attorney Address 1

P.O. Box 919016

Agent Attorney Address 2

Agent Attorney City

San Diego

Agent Attorney State/Province

CALIFORNIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

92191-9016

Agent Attorney Email

cmartorell@larrabee.com

PW Track Number

P10020037301881

PW SOC Code

15-1199

PW SOC Title

ONET Code 151199.09 IT Project Mgrs

PW Skill Level

Level IV

PW Wage

106434.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-04-29

PW Expiration Date

2020-07-28

Wage Offer From

106434.00

Wage Offer To

0.00

Average Salary

106434.00

Wage Unit of Pay

Year

Worksite Address 1

One Edwards Way

Worksite Address 2

Worksite City

Irvine

Worksite City Slug

irvine

Worksite State

CALIFORNIA

Worksite Postal Code

92614

Job Title

Associate Manager, Clinical Project Management

Job Title Slug

associate-manager-clinical-project-management

Minimum Education

Bachelor's

Major Field of Study

life sciences* (cont'd in H.14)

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

N

Accept Alternative Combination Education

Accept Alternative Combination Education Years

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

96

Accept Alternative Job Title

progressive experience in clinical research

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Contd from H.4B Biology, Pharmaceutical Sciences, Clinical Research, or a related field.br br In H.12 The position requirements are normal for the employer and within the industry. Employer marked quot;not normalquot; in H.12 due to ONET job zoneSVP analysis only.br br br Work experience to include 1. Three years of experience managing Clinical Data Management or Clinical Research projects. 2. Three years of experience utilizing Microsoft Office Word, Excel and Project Microsoft Office suite applications as well as CTMS Clinical Trial Management System, eTMF electronic Trial Master file clinical systems to complete and review clinical data documents to include Electronic Data Capture EDC documents, Data Management Plans DMP, and clinical protocols. 3. Three years of experience organizing and chairing Clinical Project Team Meetings. 4. Conducting Electronic Data Capture EDC using Rave, working with EDC systems, and conducting software testing in a clinical research environment. 5. Working with clinical protocols, Data Management Plans, and Standard Operating Procedures prepared by others. 6. Working with regulatory policies, supporting regulatory submissions, reporting, and audits as they relate to Clinical Research processes. 7. Collaborating with the Clinical Study teams throughout all the phases of the study from Initiation and Build through Study Conduct to Lock and Archive. 8. Synthesizing and summarizing clinical data into actionable information. 9. Translating clinical study business requirements into system requirements for the collection and management of data from clinical trials. Any and all experience can be gained concurrently.br Hiring Requirements Drug TestingScreening, Background Checks, Motor Vehicle Background Check.

Combination Occupation

N

Offered to Applicant Foreign Worker

Y

Foreign Worker Live on Premises

N

Foreign Worker Live in Domestic Service

N

Foreign Worker Live in Domestic Service Count

Professional Occupation

Y

Application for College/University Teacher

N

SWA Job Order Start Date

2020-05-11

SWA Job Order End Date

2020-06-11

Sunday Edition Newspaper

Y

First Newspaper Name

Orange County Register

First Advertisement Start Date

2020-06-07

Second Newspaper Ad Name

Orange County Register

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-06-14

Employer Website From Date

2021-01-01 09:24:51

Employer Website To Date

2021-01-01 09:24:51

Professional Organization Ad From Date

2021-01-01 09:24:51

Professional Organization Advertisement To Date

2021-01-01 09:24:51

Job Search Website From Date

2020-06-15

Job Search Website To Date

2020-06-19

Employee Referral Program From Date

2021-01-01 09:24:51

Employee Referral Program To Date

2021-01-01 09:24:51

Local Ethnic Paper From Date

2020-06-15

Local Ethnic Paper To Date

2020-06-15

Radio/TV Ad From Date

2021-01-01 09:24:51

Radio/TV Ad To Date

2021-01-01 09:24:51

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

INDIA

Foreign Worker Birth Country

INDIA

Class of Admission

H-1B

Foreign Worker Education

Bachelor's

Foreign Worker Information: Major

PHARMACY

Foreign Worker Years of Education Completed

2009

Foreign Worker Institution of Education

UNIVERSITY OF PUNE

Foreign Worker Education Institution Address 1

GANESHKHIND

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

PUNE

Foreign Worker Education Institution State/Province

Foreign Worker Education Institution Country

INDIA

Foreign Worker Education Institution Postal Code

411007

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Claudia P Martorell

Preparer Title

PartnerAttorney at Law

Preparer Email

Claudia@larrabee.com

Employer Information Declaration Name

Heather Sheira

Employer Information Declaration Title

Sr. Manager, Global Mobility