Senior Clinical Trial IWRS Monitor

6 days ago

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

Everest Clinical Research Services Inc is a leading contract research organization (CRO) providing comprehensive clinical research services to the pharmaceutical, biotechnology, and medical device industries.

We are seeking a highly skilled Senior Clinical Trial IWRS Monitor to join our team in Toronto, Ontario, Canada or remotely from a home-based office anywhere in Canada.

Key Responsibilities:

  • Act as primary contact with clients, building and maintaining relationships through work deliveries, solution designs, issue resolution, and escalations.
  • Support client requests and issue analysis, problem solving, and resolution, working closely with internal teams.
  • Perform medium-complexity drug management analysis and forecasting to ensure site and study drug inventory is managed effectively.
  • Monitor data generated within CTT 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 CTT Clinical Monitor resources or the outsourced call center service.
  • Monitor all studies involved with CTT to ensure accuracy and quality of the data.
  • Manage risks, issues, and escalations and work with teams in identifying mitigation/remediation options.
  • Perform final review and quality control checks and verification on junior CTT monitors work assignments.
  • Provide excellent client service and support during start-up activities.
  • Generate, maintain, and/or review CTT Requirements Specification documents.
  • Develop CTT study test plans for newly developed projects or perform User Acceptance Testing (UAT) on newly developed projects with CTT.
  • 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 IWRS demonstrations to Sponsors, as well as 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.
  • Drive, collaborate, and support 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 which will improve efficiency, effectiveness, user satisfaction, and market competitiveness.
  • Provide analytical, report generation, and project execution support to CTT and Everest management team members.
  • Lead and support ad hoc business development initiatives for the CTT unit.
  • Drive, develop, and recommend the development of new CTT-related SOPs, processes, and procedures.
  • Train, manage, and mentor junior CTT monitors on monitoring and training activities.

Requirements:

  • A bachelors' degree in health science, physical or biological fields, or computer science.
  • At least five years of experience in clinical trial data processing and management.
  • Experience in clinical research, call center support, pharmaceutical sciences.
  • Ability to think on the spot and apply critical thinking skills to triage user issues and formulate optimal responses.
  • Ability to effectively and appropriately interact with clients and Everest internal staff via phone and written email communications.
  • At least four or more years of experience in clinical trial data processing, technology delivery, process analysis and design, software development lifecycle, software testing, and project management.
  • Experience with client relationship management.
  • Comfortable using web application technologies and has prior customer service/support experience.
  • Comfortable with technology and web-based tools.
  • Excellent voice, courtesy, and interpersonal communication skills that provide an exceptional customer service experience.
  • Aptitude to learn and retain CTT application rules and support procedures and broader related clinical trials processes to effectively troubleshoot and support user inquiries.
  • Adaptive to varying customer knowledge and skill levels (patience).
  • Adhere to all company security and privacy standards, and other policies and SOPs.
  • Good organizational skills and the ability to handle multiple tasks.

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