A biotech company in Massachusetts has a great Remote contract opportunity awaiting a new Clinical Systems Specialist. In this role, the Clinical Systems Specialist will be responsible for supporting the lifecycle management of clinical systems for Global Development Operations.
***To be considered for this opportunity, the qualified professional must be able to work on a W2 basis. ***
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 fixes and upgrades
- Build out Dashboard and 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 the administration activities of clinical systems (e.g., User Management)
- Partner with internal teams to analyze clinical systems and vendor performance to ensure compliance with contracted services
- Support end users as an internal clinical systems subject matter expert
- Perform other duties, as needed
Qualifications:
- 2+ years of Clinical Systems experience (eCOA, eDiary, eConsent, CTMS, IRT, eTMF, etc.)
- Bachelor’s Degree or equivalent
- Solid understanding of Clinical Trial Operations & Regulations (Good Clinical Practice, 21 CFR Part 11)
- Experience in developing User Acceptance Testing scenarios for computer systems
- Experience or good knowledge with Databases and Reports
- Microsoft Office proficient (Excel, Outlook, PowerPoint, SharePoint, Word, Visio, etc.)
- Solid problem-solving and time management skills
- Great interpersonal skills
- Excellent communication skills (written and verbal)
- Strong attention to detail
- Highly organized
Desired Skills:
- Bachelor’s Degree in a Scientific and/or Technical-related field
