Clinical System Leader
TalentBurst, Inc.
South San Francisco, CA
South San Francisco CA
12 Months
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.
- Collaboration and Teamwork: 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. Work independently with PET stakeholders and/or cross-functional project teams with little to no oversight. Works collaboratively with the ECD I&A team to share knowledge.
- Issue and Risk Management: 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.
- Communication & Presentation Skills: 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.
- 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
Working Model: Hybrid (three days in office, two remote) - Anchor Days are Tuesday through Thursday
Interview Format: Two rounds (1 - virtual; 2 in-person)
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About the Company
TalentBurst, Inc.
For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.
Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!