Clinical Trial IWRS Monitor I

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan. Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success. Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest. To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as a Clinical Trials IWRS Monitor for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy. Key Accountabilities: 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 request 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. This includes daily checks of automated data queries built in the CTT applications, as well as weekly manual checks of the data generated from the system. Coordinate and verify changes to the database and application using appropriate change control procedures and ensure comprehensive and accurate documentation is completed. Act as off-hours escalation point for junior IWRS Clinical Monitor resources or the outsourced call centre service to resolve high urgency client requests (based on agreed rotational schedule amongst IWRS Clinical Trials Monitor resources). 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 (newly developed applications or application change requests). These tasks are performed in a systematic and very detailed manner using the CTT Requirements Specification document as the base for testing CTT functionality. Generate, maintain, and/or review Quick Reference Guides for all CTT studies. Conduct CTT 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 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 to support CTT product development planning. Provide analytical, report generation, and project execution support to CTT and Everest management team members for internal CTT capability development initiatives. Qualifications and Experience: A Bachelors’ 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.