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Clinical System Analyst
Work from home
#670088
Remote / WFH
Job Description
Job Title: Clinical Systems Leader
Duration: 12 Months
Location: South San Francisco, CA/Hybrid
Pay Rate: $50/hr
Job Description:
The Clinical Systems Leader (CSL) is responsible for implementing all related clinical systems actions used in the development of clinical trials within Early Clinical Development (ECD). The CSL collaborates with a cross-functional team of internal stakeholders and technology vendors to ensure the successful implementation and maintenance of technology solutions supporting clinical trials.
Primary Responsibilities:
● Study Execution and System Management: Accountable for implementing all related clinical systems, such as Interactive Response Technologies (IxRS) and electronic Clinical Outcome Assessments (eCOA) actions for the ECD portfolio.
● Project Management: Closely manage study-related timelines and associated activities. Manage and lead the end-to-end specifications for the build of clinical systems for an assigned study or enterprise project. This includes requirements review, testing, deployment, maintenance, enhancement, and closeout.
● Technical Oversight: Provide technical oversight to ensure that clinical systems solutions (e.g.,IxRS/eCOA) adhere to the study protocol, industry regulations/best practices, and company policies, procedures, and guidelines.
Who You Are:
● Bachelor's Degree in life science, computer science, engineering, information system, data science or related discipline
● 2-5 years of experience in Clinical Operations, or Clinical Systems Management
● 2-5 years of IxRS/IRT and clinical-related systems experience
● Successful track records in leading the implementation of clinical systems, such as IxRS/IRT, ePRO, and eCOA
● Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution
● Excellent written and verbal communication skills and strong project management skills
● Familiar with documentation in a regulated environment. Experience in Veeva is a plus
Equal Employment Opportunity Statement
Intelliswift celebrates a diverse and inclusive workforce. We offer equal employment opportunities to all applicants and employees. All qualified applicants will be considered regardless of race, color, sex, gender identity, gender expressions, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, ****** orientation, genetic information, military or veteran status, or any other protected basis under the law.
Americans with Disabilities Act (ADA)
If you require a reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please contact Intelliswift Human Resources Department
Other Employment Statements
Intelliswift participates in the E-Verify program.
Learn More
For information on Intelliswift Software, Inc., visit our website at www.intelliswift.com.
Duration: 12 Months
Location: South San Francisco, CA/Hybrid
Pay Rate: $50/hr
Job Description:
The Clinical Systems Leader (CSL) is responsible for implementing all related clinical systems actions used in the development of clinical trials within Early Clinical Development (ECD). The CSL collaborates with a cross-functional team of internal stakeholders and technology vendors to ensure the successful implementation and maintenance of technology solutions supporting clinical trials.
Primary Responsibilities:
● Study Execution and System Management: Accountable for implementing all related clinical systems, such as Interactive Response Technologies (IxRS) and electronic Clinical Outcome Assessments (eCOA) actions for the ECD portfolio.
● Project Management: Closely manage study-related timelines and associated activities. Manage and lead the end-to-end specifications for the build of clinical systems for an assigned study or enterprise project. This includes requirements review, testing, deployment, maintenance, enhancement, and closeout.
● Technical Oversight: Provide technical oversight to ensure that clinical systems solutions (e.g.,IxRS/eCOA) adhere to the study protocol, industry regulations/best practices, and company policies, procedures, and guidelines.
Who You Are:
● Bachelor's Degree in life science, computer science, engineering, information system, data science or related discipline
● 2-5 years of experience in Clinical Operations, or Clinical Systems Management
● 2-5 years of IxRS/IRT and clinical-related systems experience
● Successful track records in leading the implementation of clinical systems, such as IxRS/IRT, ePRO, and eCOA
● Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution
● Excellent written and verbal communication skills and strong project management skills
● Familiar with documentation in a regulated environment. Experience in Veeva is a plus
Equal Employment Opportunity Statement
Intelliswift celebrates a diverse and inclusive workforce. We offer equal employment opportunities to all applicants and employees. All qualified applicants will be considered regardless of race, color, sex, gender identity, gender expressions, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, ****** orientation, genetic information, military or veteran status, or any other protected basis under the law.
Americans with Disabilities Act (ADA)
If you require a reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please contact Intelliswift Human Resources Department
Other Employment Statements
Intelliswift participates in the E-Verify program.
Learn More
For information on Intelliswift Software, Inc., visit our website at www.intelliswift.com.
