Fiscal Year

2024

Case Number

A-22289-40239

Case Status

Certified-Expired

Received Date

2022-12-22

Decision Date

2023-12-06

Refile

N

Original File Date

2024-01-01 00:23:01

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

MIRATI THERAPEUTICS, INC.

Employer Name Slug

mirati-therapeutics-inc

Employer Address 1

3545 CRAY COURT

Employer Address 2

Employer City

SAN DIEGO

Employer City Slug

san-diego

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

92121

Employer Phone

(619) 816-4090

Employer Number of Employees

184

Employer Year Commenced Business

2013

NAICS Code

541711

FW Ownership Interest

N

Employer Contact Name

Laura Hughes-Ricci

Employer Contact Address 1

3545 Cray Court

Employer Contact Address 2

Employer Contact City

San Diego

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

92121

Employer Contact Phone

(619) 886-9362

Employer Contact Email

Hughes-RicciL@Mirati.com

Agent Attorney Name

Grace A Zimmerman

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

Grace@larrabee.com

PW Track Number

P10022081997324

PW SOC Code

15-2051.02

PW SOC Title

Clinical Data Managers

PW Skill Level

Level IV

PW Wage

139568.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-11-30

PW Expiration Date

2023-06-30

Wage Offer From

140000.00

Wage Offer To

0.00

Average Salary

140000.00

Wage Unit of Pay

Year

Worksite Address 1

3545 Cray Court

Worksite Address 2

Worksite City

San Diego

Worksite City Slug

san-diego

Worksite State

CALIFORNIA

Worksite Postal Code

92121

Job Title

Principal Clinical Data Manager

Job Title Slug

principal-clinical-data-manager

Minimum Education

Bachelor's

Major Field of Study

Life Sciences, Computer Science, Mathematics, or a related field

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

See H.4B.

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

72

Accept Alternative Job Title

progressive data management experience in the CRO, pharmaceutical, or biotechnology environment

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Contd from H.12 Job requirements are normal for the employer due to the complexity of job duties associated with this position. Employer answered no to Question H.12 based on SVP analysis only.br br Work experience to include 1. Working in EDC clinical data management system. 2. Utilizing clinical data management principles, supporting clinical trials processes, and working with regulatory requirements. 3. Utilizing medical coding dictionaries, including MedDRA and WHODrug. 4. Working with industry standards CDISC, SDTM, and CDASH, SAS, 21 CFR Part 11, ICH guidelines, and FDA regulations. 5. Performing data management activities for clinical studies, including development of internal data management processes. 6. Supporting clinical studies from inception to close, including reviewing and contributing to study protocols, CRF Case Report Form design, performing and coordinating UAT User Acceptance Testing, reviewing CRF completion guidelines, data management plans, edit check specifications, external data transfers, performing data quality checks, discrepancy management, and database lock activities. 7. Collaborating with multidisciplinary teams including any 2 of the following Clinical Science, Biostatistics, Medical, Clinical Safety, or CROs for CRF design, data review and cleaning, database lock, and receipt of final database deliverables. 8. Supporting analysis of regulatory submissions, safety monitoring, and publications. 9. Participating in the development of data management Standard Operating Procedures SOPs, processes and CRF standards to ensure adherence to industry standards CDISC, SDTM, and CDASH, Good Clinical Practices GCP, Good Clinical Data Management Practices GCDMP and internal and external customer requirements.

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

2022-08-15

SWA Job Order End Date

2022-09-16

Sunday Edition Newspaper

Y

First Newspaper Name

San Diego Union Tribune

First Advertisement Start Date

2022-08-21

Second Newspaper Ad Name

San Diego Union Tribune

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-08-28

Employer Website From Date

2022-08-17

Employer Website To Date

2022-08-22

Professional Organization Ad From Date

2024-01-01 00:23:01

Professional Organization Advertisement To Date

2024-01-01 00:23:01

Job Search Website From Date

2022-08-25

Job Search Website To Date

2022-09-05

Employee Referral Program From Date

2024-01-01 00:23:01

Employee Referral Program To Date

2024-01-01 00:23:01

Local Ethnic Paper From Date

2024-01-01 00:23:01

Local Ethnic Paper To Date

2024-01-01 00:23:01

Radio/TV Ad From Date

2024-01-01 00:23:01

Radio/TV Ad To Date

2024-01-01 00:23:01

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

CHEMISTRY

Foreign Worker Years of Education Completed

2017

Foreign Worker Institution of Education

WESTERN ILLINOIS UNIVERSITY

Foreign Worker Education Institution Address 1

1 UNIVERSITY CIRCLE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

MACOMB

Foreign Worker Education Institution State/Province

IL

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

61455

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Grace A Zimmerman

Preparer Title

Partner Attorney at Law

Preparer Email

Grace@larravee.com

Employer Information Declaration Name

Michael E Paolucci

Employer Information Declaration Title

EVP, Chief People Officer