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Senior Medical Information Technology Specialist

求人ID 65348BR ロケーション アメリカ合衆国 仕事内容
As a Medical Information Technology Specialist at Parexel, you will have the opportunity to bring your technical expertise to our operational business unit as the subject matter expert and Technical system administrator for the Argus safety database. While leading Argus Safety business configuration activities you will work both cross-functionally and as well as with clients directly.

In this role you will:
• Support and where necessary lead migration of legacy data from client/partner safety databases to the Parexel Argus Safety database
• Perform Argus Safety business configuration activities (studies, products, report rules, periodic report configuration & generation)
• Act as SME for
o E2B R2 and R3 specifications
o E2B import and export functionality (including EMA, FDA, & Argus Safety business rules)
• Lead Development & creation of data migration plans; data migration summary reports; test strategy documents
• Lead Development of novel methods to import/export data that is not part of the standard E2B specification
• Work closely with Parexel IT, vendor, and/or Parexel Safety Services staff proper analysis, resolution and closure of issues for supported systems
• Interface with other Parexel groups (such as TQM, IT) to ensure that database, hardware, network, security, quality, integration, support and project services associated with maintained systems are adequate and sufficiently managed
• Support the handover of the safety database from client to Parexel where contracted to take over the pharmacovigilance tasks for client projects.
• Support the handover of safety data from Parexel to client at the end of study/project as contracted
• Act as a point of contact both internally and with external clients to develop programs and processes to meet requirements of both clients and regulatory agencies
• Provide technology support to Safety Services for the purposes of business process optimization and improvement
• Support software updates, change requests and application support for the supported applications
• Ensure adherence to regulations concerning computer system validation, 21 CFR Part 11 compliance, procedures, and quality standards

Qualifications

Qualifications:
  • Excellent interpersonal, verbal and written communication skills
  • CRO experience strongly preferred
  • Client-focused approach to work
  • A flexible attitude with respect to work assignments and new learning
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
  • Excellent problem-solving skills.
  • Strong understanding of E2B R2 and R3 specifications and Regulatory processes

Knowledge and Experience:
  • Knowledge of principles of GxP, system validation and change control required
  • Ability to work in a matrix environment with Parexel project team members and clients with limited oversight to meet defined timelines
  • ARGUS Safety database experience required
  • Understanding of the Clinical Research and development process including post-marketing approval, in particular with respect to patient safety and regulatory reporting requirements.
  • Bachelor’s degree required

EEO Disclaimer

Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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