Clinical Trials IWRS Monitor

4 weeks ago

Markham, Ontario, Canada Everest Clinical Research Services Inc Full time

Everest Clinical Research Services Inc is a leading contract research organization (CRO) providing a range of clinical research services to pharmaceutical, biotechnology, and medical device industries. We serve some of the world's most renowned companies and work with innovative drugs, biologics, and medical devices in development.

We are seeking a skilled and customer-focused individual to join our team as a Clinical Trials IWRS Monitor. This role will involve working closely with our IWRS/IRT and eDiary team to provide exceptional support to our clients.

Key Responsibilities:

  • Act as primary contact with CTT Users for the Everest IWRS/IRT and eDiary team via the CTT Helpdesk telephone or IWRS helpdesk email accounts.
  • Support client requests and issue analysis, problem solving, and resolution, working closely with CTT Developers and internal Everest Data Management and Statistical & Programming teams.
  • Monitor data generated within CTT applications to ensure accuracy and quality.
  • Coordinate and verify changes to the database and application using appropriate change control procedures.
  • Act as off-hours escalation point for junior IWRS Clinical Monitor resources or the outsourced call centre service to resolve high urgency client requests.
  • Generate, maintain, and/or review CTT Requirements Specification documents.
  • Execute CTT application test planning, test plan, and test script development and Stage I and II testing activities for CTT applications.
  • Generate, maintain, and/or review Quick Reference Guides for all CTT studies.
  • Conduct CTT demonstrations to sponsors and training demonstrations to study team members.
  • Support communications and coordination with Sponsors, Study Team Members, Depot personnel and internal Everest data management and statistical leads across the IWRS development lifecycle.
  • Cooperate with and assist, when required, data management quality assurance (QA) personnel in performing QA procedures on CTT applications.
  • Analyze CTT monitoring and support trends to identify new CTT core features that will improve efficiency, effectiveness, user satisfaction and market competitiveness.

Requirements:

  • A Bachelor's degree in health science, physical or biological fields with at least 3 years' experience in clinical trial data processing and management.
  • Education or experience must demonstrate the ability to work independently, to have a clear, professional and energetic telephone voice, and detailed approach to data review and system development.

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