Fiscal Year

2022

Case Number

A-21326-76526

Case Status

Certified

Received Date

2021-12-21

Decision Date

2022-08-01

Refile

N

Original File Date

2022-01-01 11:48:03

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

AMGEN INC.

Employer Name Slug

amgen-inc

Employer Address 1

ONE AMGEN CENTER DRIVE

Employer Address 2

Employer City

THOUSAND OAKS

Employer City Slug

thousand-oaks

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

91320

Employer Phone

805-447-1000

Employer Number of Employees

12973

Employer Year Commenced Business

1980

NAICS Code

54171

FW Ownership Interest

N

Employer Contact Name

Jenny Cummings

Employer Contact Address 1

2202 N. Westshore Blvd.

Employer Contact Address 2

Employer Contact City

Tampa

Employer Contact State/Province

FLORIDA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

33607

Employer Contact Phone

813-392-0428

Employer Contact Email

jen01@amgen.com

Agent Attorney Name

Laura Bloniarz

Agent Attorney Firm Name

Berry Appleman Leiden LLP

Agent Attorney Phone

972-900-1471

Agent Attorney Address 1

2400 N. Glenville Dr

Agent Attorney Address 2

Building A

Agent Attorney City

Richardson

Agent Attorney State/Province

TEXAS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

75082

Agent Attorney Email

labloniarz@bal.com

PW Track Number

P10021092193004

PW SOC Code

11-9111

PW SOC Title

Medical and Health Services Managers

PW Skill Level

Level I

PW Wage

85634.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-09-02

PW Expiration Date

2022-06-30

Wage Offer From

124994.11

Wage Offer To

0.00

Average Salary

124994.11

Wage Unit of Pay

Year

Worksite Address 1

1120 Veterans Blvd.

Worksite Address 2

Worksite City

South San Francisco

Worksite City Slug

south-san-francisco

Worksite State

CALIFORNIA

Worksite Postal Code

94080

Job Title

Clinical Data Management Manager

Job Title Slug

clinical-data-management-manager

Minimum Education

Master's

Major Field of Study

See H.14

Required Training

N

Required Experience

Y

Required Experience Months

24

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

Y

Accept Alternative Combination Education

Bachelor's

Accept Alternative Combination Education Years

5

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

24

Accept Alternative Job Title

See H.14

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Masters degree in Life Sciences, Health Services Administration, Business Administration or related field and 2 years of experience in the following Utilizing Medidata Rave EDC system, Rave Safety Gateway RSG, Medidata Coder, or iMedidata platform to lead fitforpurpose technical discussions in clinical study teams and participate in creative design sessions tobr support clinical trial business processes; Integrating EDC with other clinical technologies including Interactive Voice Response Systems IVRS, clinical trial management system CTMS, Oracle Argus Safety, ePRO or other related technology in the pharmaceutical or biotechnology industry; Employing good clinical practices and global regulatory regulations; Applying Information Technology Infrastructure Library ITIL v3, and basic Industry Information Systems best practices; and Overseeing outside vendors such as Contract Research Organizations CROs, central labs and imaging vendors.br br ORbr br Bachelors degree in Life Sciences, Health Services Administration, Business Administration or related field and 5 years of progressive experience in the following Utilizing Medidata Rave EDC system, Rave Safety Gateway RSG, Medidata Coder, or iMedidata platform to lead fitforpurpose technical discussions in clinical study teams and participate in creative design sessions to support clinical trial business processes; Integrating EDC with other clinical technologies including Interactive Voice Response Systems IVRS, clinical trial management system CTMS, Oracle Argus Safety, ePRO or other related technology in the pharmaceutical or biotechnology industry; Employing good clinical practices and global regulatory regulations; Applying Information Technology Infrastructure Library ITIL v3, and basic Industry Information Systems best practices; and Overseeing outside vendors such as Contract Research Organizations CROs, central labs and imaging vendors.br br Any suitable combination of experience, training or education is acceptable.

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

2021-09-23

SWA Job Order End Date

2021-10-25

Sunday Edition Newspaper

Y

First Newspaper Name

San Francisco Chronicle

First Advertisement Start Date

2021-10-10

Second Newspaper Ad Name

San Francisco Chronicle

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-10-17

Employer Website From Date

2022-01-01 11:48:03

Employer Website To Date

2022-01-01 11:48:03

Professional Organization Ad From Date

2021-10-06

Professional Organization Advertisement To Date

2021-10-13

Job Search Website From Date

2021-10-06

Job Search Website To Date

2021-10-13

Employee Referral Program From Date

2022-01-01 11:48:03

Employee Referral Program To Date

2022-01-01 11:48:03

Local Ethnic Paper From Date

2021-10-14

Local Ethnic Paper To Date

2021-10-14

Radio/TV Ad From Date

2022-01-01 11:48:03

Radio/TV Ad To Date

2022-01-01 11:48:03

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

Master's

Foreign Worker Information: Major

HEALTH SERVICES ADMINISTRATION

Foreign Worker Years of Education Completed

2016

Foreign Worker Institution of Education

MISSISSIPPI COLLEGE

Foreign Worker Education Institution Address 1

200 S. CAPITOL STREET

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

CLINTON

Foreign Worker Education Institution State/Province

MS

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

39056

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Laura Bloniarz

Preparer Title

Sr. Associate Immigration Attorney

Preparer Email

labloniarz@bal.com

Employer Information Declaration Name

Jen Cummings

Employer Information Declaration Title

HR Representative