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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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Clinical Systems Specialist
Remote, TX US
Posted: 06/10/2025
2025-06-10
2025-07-15
Employment Type:
Contract
Job Category: Operations and Development
Job Number: 4472
Job Description
The Clinical Systems Specialist is responsible for supporting the lifecycle management of clinical systems for Global Development Operations. This position will provide support for clinical systems, such as eCOA, eDiary, eConsent, eTMF, Interactive Response Technology (IRT), and Clinical Trial Management System (CTMS) used in clinical trials. The Clinical Systems Specialist has expertise and practical experience in clinical trial management, clinical systems, reporting and vendor management
Responsibilities:
Responsibilities:
- Work on planning, design, configuration and deployment of new clinical systems and enhancements to existing applications; coordinate and participate in analyzing system requirements, defining user acceptance scenarios and user acceptance testing and system enhancements, as necessary.
- Partner with IT, Quality Systems and Global Development Operations stakeholders on all clinical system bug fix and upgrades.
- Build Dashboard, Power BI reports, as needed.
- Collaborate with Clinical Operations and Clinical Vendor Management in managing the systems vendor relationship on a day-to-day basis to ensure optimum system performance and to address/escalate issues, as appropriate.
- Develop Standard Operating Procedures (SOPs) and guidelines related to the management and use of clinical systems.
- Provide training on different clinical systems, as necessary.
- Support administration activities of clinical systems (e.g., User Management).
- Partner with internal teams to analyze clinical systems and vendor performance to ensure compliance against contracted services.
- Support end users as an internal clinical systems subject matter experience.
- Bachelor’s degree or equivalent required (scientific or technical discipline preferred)
- 2 years of clinical systems experience (eCOA, eDiary, eConsent, CTMS, IRT, eTMF, etc.)
- PC literacy required; common MS application skills SharePoint, Outlook, Word, Excel, PowerPoint, Visio); experience or good knowledge with databases and reports
- Understanding of clinical trial operations and regulations (Good Clinical Practice, 21 CFR Part 11)
- Experience in developing user acceptance testing scenarios for computer systems
- Must have the ability to build and maintain positive relationships with management and peers
- Excellent written and verbal skills required. Must display strong analytical and problem-solving skills. Attention to detail required
- Good organization skills, ability to manage multiple tasks
- Ability to deal with time demands, incomplete information or unexpected events