Clinical Systems Specialist

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