Overview
Skills
Job Details
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)
Bachelor's Degree in a Scientific and/or Technical-related field