Arcus Biosciences Inc

Associate Director, Clinical Data Management

A-23109-29700 H-1B 2023 Withdrawn

Salary

$179,878

Visa Type

H-1B

Job Title

Associate Director, Clinical Data Management

Employee's Citizenship

INDIA

Graduate School

SOUTHEAST MISSOURI STATE UNIVERSITY

Case info Company Info HR Info Attorney Position Info Employee Info

Case info

9 fields

Data Publish Year 2023

Case Number A-23109-29700

Case Status Withdrawn

Received Date 2023-05-05

Decision Date 2023-07-06

Refile N

Original File Date -

Previous State Work Force Agency (SWA) Case Number Stete -

Schedule A or a Sheepherder Occupation N

Company Info

14 fields

Employer Name Arcus Biosciences Inc

Employer Address_Line 1 3928 Point Eden Way

Employer Address_Line 2 -

Employer City Hayward

State -

Employer State/ Province CALIFORNIA

Employer Country UNITED STATES OF AMERICA

Employer Postal Code 94545

Employer Phone No. (510) 694-6200

Employer Phone Extent No. -

Total Number of Employees 556

Employer Year of Commenced 2015

NAICS Code 541711

Foreign Worker Ownership & Interest N

HR Info

9 fields

Employer Contact Name Lori Moraca

Employer Contact Address Line1 3928 Point Eden Way

Employer Contact Address Line2 -

Employer Contact City Hayward

Employer Contact State/ Provice CALIFORNIA

Employer Contact Country UNITED STATES OF AMERICA

Employer Contact Post Code 94545

Employer Contact Phone (510) 764-3826

Employer Contact Email lmoraca@arcusbio.com

Attorney

11 fields

Agent/ Attorney Name Ilana J Drummond

Agent/ Attorney Firm Name -

Agent/ Attorney Phone 4159864559

Agent/ Attorney Phone Ext. -

Agent/ Attorney Address Line 1 909 Montgomery Street

Agent/ Attorney Address Line 2 Suite 200

Agent/ Attorney City San Francisco

Agent/ Attorney State/ Province CALIFORNIA

Agent/ Attorney Country UNITED STATES OF AMERICA

Agent/ Attorney Postal Code 94133

Agent/ Attorney Email idrummond@jackson-hertogs.com

Position Info

89 fields

Prevailing Wage Track Number P10022019839727

Prevailing Wage SOC Code 15-2051.00

Prevailing Wage SOC Title Data Scientists

Prevailing Wage Skill Level Level IV

Prevailing Wage 179878

Prevailing Wage Unit of Pay Year

Prevailing Wage Source OES

Prevailing Wage Other Source -

Prevailing Wage Determination Date 2023-01-06

Prevailing Wage Expiration Date 2023-06-30

Wage Offer From 179878

Wage Offer To 257689

Wage Offer Unit of Pay Year

Workstie Address Line 1 3928 Point Eden Way

Worksite Address Line 2 -

Worksite City Hayward

Worksite State CALIFORNIA

Worksite Postal Code 94545

Job Title Associate Director, Clinical Data Management

Minimum Education Master's

Other Degree/ Diploma -

Major Field of Study Pharmaceutical Sciences

Required Training N

Required Training Month -

Required Field of Training -

Required Experience N

Required Expreience Months -

Accept Alternate Field of Study Y

Accept Alternate Major Chemistry, Natural Science, Biostatistics, or related field

Alternate Combination of Education/ Experience N

Required Alternate Level of Education -

Other Alternate Level of Education -

Acceptable Years of Experience -

Accept Foreign Educationa Y

Acceptable Alternate Occupation Y

Acceptable Alternate Occupation Month 96

Accept Alternate Job Title Sr. Clinical Data Mang., Clinical Solutions Project Mang., Lead Clinical Data Mang., or rel occp.

Normal Requirements of Job Opportunity N

Required Foreign Language N

Specific Skills 1.Applying drug development process including experience in early phase oncology clinical trials and response criteria such as RECIST.br 2.Training and managing staff internal, contract, and CRO to support the clinical data management team on projects and deliverables within the clinical data management function.br 3.Using electronic data capture EDC tools including Medidata Rave, Oracle Clinical, and Inform to perform clinical trials.br 4.Applying ICH and GCP guidelines to clinical data management.br 5.Leading or participating in the development, reviewing, and implementing processes, SOPs, and standard templates for clinical data management.br 6.Providing direction and leadership in CRO and vendor selection and management.br 7.Ensuring that CDM related documentation to support regulatory submissions and inspections are maintained to standard requirements.br 8.Leading and overseeing all data management activities for multiple clinical trials including designing case report forms and completing guidelines for eCRF, designing, and testing EDC systems, developing edit checks, developing data management plan, and developing data transfer agreements, SAE reconciliation, database freeze and lock activities.br 9.Participating in the generation and approval of budgets and timelines.br br Position requires up to 25 travel.br br Position permits telecommuting, applicant may reside anywhere in U.S. and report to Hayward, CA. Any incurred business travel will be fully reimbursed.br br Position supervises 1 Job title Manager, Clinical Data Management

Combination Occupation N

Offered to Applied Foreign Worker Y

ForeignWorker Live on Premises N

Live in Domestic Service Worker N

Employment Contract -

Professional Occupation Y

College/ University Teacher N

Competitive Process -

Basic Recruitment Process -

Teacher Select Date -

Teacher Publish Journal Name -

Additional Recruitment Information -

Job Oder Start Date 2023-02-23

Job Oder End Date 2023-03-30

Sunday Edition Newspaper Y

First Newspaper Name East Bay Times

First Advertisement Start Date 2023-03-05

Second Newspaper Name East Bay Times

Second Advertisement Type Newspaper

Second Ad Start Date 2023-03-12

Job Fair From Date -

Job Fair to Date -

On Campus Recruiting from Date -

On Campus Recruiting to Date -

Employer Website from Date -

Employer Website to Date -

Pro. Org. Ad from Date 2023-03-06

Pro.Org. Ad to Date 2023-03-20

Job Search Website from Date 2023-03-03

Job Search Website to Date 2023-03-17

Private Employment Firm from Date -

Pricate Employment Firm to Date -

Employee Referral Program from Date -

Employee Referral Program to Date -

Campus Placement from Date -

Campus Placement to Date -

Local Ethnic Newspaper from Date 2023-03-10

Local Ethnic Newspaper to Date 2023-03-10

Radio/TV Ad from Date -

Radio/TV Ad to Date -

Employer Received the Payment N

Payment Details -

Bargaining Representative Notified N/A

Posted Notice at Worksite Y

Layoff in Past Six Months N

US Worker Considered -

Country of Citizenship INDIA

Foreign Worker Birth Country INDIA

Class of Admission H-1B

Employee Info

24 fields

Foreign Worker Education Master's

Foreign Worker Education Other -

Foreign Worker Major MASTER OF NATURAL SCIENCES

Year of Compelted Education 2012

Foreign Worker Istitution of Eduation SOUTHEAST MISSOURI STATE UNIVERSITY

Foreign Worker Education Instution Address Line 1 ONE UNIVERSITY PLAZA

Foreign Worker Education Institution Address Line 2 -

Foreign Worker Education Institution City CAPE GIRARDEAU

Foreign Worker Educatution Institution State MO

Foreign Worker Education Institution Country UNITED STATES OF AMERICA

Foreign Worker Education Training Post Code 63701

Foreign Worker Training Completion N/A

Foreign Worker Required Experience N/A

Foreign Worker Alternate Education and Experience N/A

Foreign Worker Alternate Occupation Experience Y

Foreign Worker Experience with Employer N

Foreign Worker Employer Pay for Education N

Foreign Worker Currently Employed Y

Employer Completed Application N

Preparer Name Ilana J Drummond

Preparer Title Partner

Preparer Email idrummond@jackson-hertogs.com

Employer Information Declaration Name Lori Moraca

Employer Declaration Title Senior HR Associate