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
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: