Imaging Endpoints - IT Specialist - Citrix / Active Directory

Description

Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO).

We are passionately focused on our vision to Connect Imaging to the CureTM.

Everything we do is aligned with this singular purpose.

We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind.

We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trials imaging to optimize the opportunity to demonstrate efficacy.

Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India and Shanghai, China.

We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL / RadPartners), the largest private radiology group in the United States.

We are recognized as the worlds largest and most preeminent iCRO in oncology.

The primary responsibility of the IT QA Specialist is to assist in the management of areas of Quality Assurance (QA) and Information Technology (IT) related to Imaging Endpoints (IE) Core Lab Quality Management System (QMS).

The IT QA Specialist positions will be solutions-oriented, facilitate timely quality decisions, and meet the needs of the business and all stakeholders with respect to quality assurance principles and practices.

ROLE : IT QA :

• Provide quality system management within the regulations of investigational products and quality standards, specifically, 21 CFR Part 312, 21 CFR Part 211, 21 CFR Part 11, and ISO 13485.
• Provide direct QA support related to the IE QMS and Innovation and IT infrastructure.
• Develop, revise, implement, maintain the companys Installation Qualifications (IQs), Operational Qualifications (OQs) and Performance Qualifications (PQs) to ensure system

hardware and software validations follow all relevant regulations.

management tools and electronic systems.

system strategies and plans to facilitate continuous improvement of the regulated electronic

systems.

Education And Experience

operating systems (Windows 10, macOS) preferred.

QMS Experience Is Preferred.

Skills

Excel and PowerPoint (statistics, graphing, presentations, etc.).

approaches or methods to fit the situation best, and deal with change, delay, or unexpected events.

(ref : hirist.tech)

Skills Required

Windows Server, Iso 13485, Microsoft Office 365, Citrix, Microsoft Office, Active Directory, VMware, 21 Cfr Part 11, electronic document management , Macos, Windows 10