Consultant Specialists, Inc. (CSI) · 1 day ago
Clinical Systems Leader
South San Francisco, CA
Contract
Onsite
Entry, Mid Level
$35/hr - $49/hr
2+ years expConsultant Specialists, Inc. (CSI) is seeking a Clinical Systems Leader responsible for implementing clinical systems in the development of clinical trials. The role involves collaboration with internal teams and technology vendors to ensure successful implementation and maintenance of clinical trial technology solutions.
Staffing & Recruiting
Hiring Manager
Maurice Minnis
Responsibilities
Accountable for implementing all related clinical systems, such as Interactive Response Technologies (IxRS) and electronic Clinical Outcome Assessments (eCOA) actions for the ECD portfolio
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
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
Work with a cross-functional team of internal stakeholders (including but not limited to: Clinical Trial Leader, Biostatistician, Drug Supply Chain, Data Management functions, and Procurement) and technology vendors
Proactively identify and track study-level technical issues to resolution
Ensure prompt resolution of system issues, document issues and risks, and implement mitigation plans in partnership with the study team and technology vendor project manager
Strong verbal and written communication skills; strong business presentation skills; Able to explain technical issues and communicate clearly, concisely, and professionally with internal, external stakeholders and departmental leadership
Qualification
Required
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
Preferred
Experience in Veeva is a plus
Company
Consultant Specialists, Inc. (CSI)
Consultant Specialists, Inc. is a small, specialized firm, built and operated by staffing industry veterans with many years experience.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase