Senior Clinical Trial IWRS Monitor

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, and Shanghai (Pudong Zhangjiang New District), China.

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 committed, skilled, and customer-focused individuals to join our winning team as  Senior Clinical Trial 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 a lead and primary contact with the client, building and maintaining relationships through work deliveries, solution designs, issue resolution, and escalations.
• Act as primary contact with CTT Users for the Everest IWRS / IRT and eDiary team via the CTT Helpdesk telephone or Helpdesk email accounts.
• Support client request and issue analysis, problem solving, and resolution, working closely with CTT Developers, internal Everest Data Management, Clinical Operations, Project Management, Quality and Compliance, and Statistical and Programming teams.
• Perform medium-complexity drug management analysis and forecasting as required to ensure site and study drug inventory is managed effectively.
• Monitor data generated within CTT 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, ensuring comprehensive and accurate documentation is completed.
• Act as off-hours escalation point for junior CTT Clinical Monitor resources or the outsourced call center service to resolve high urgency client requests (based on agreed rotational schedule amongst CTT Clinical Trials Monitor resources).
• Monitor all studies involved with CTT to ensure accuracy and quality of the data, including the development of SAS checks for CTT applications to ensure quality and accuracy.
• 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 to ensure activities are executed per SOPs and with quality.
• Provide excellent client service and support during start-up activities, demonstrating subject matter knowledge and providing guidance and advice on solution designs and processes.
• 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 (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 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 across the CTT development lifecycle.
• Drive, collaborate, and support, 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 which 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 product / capability development initiatives.
• Lead and support ad hoc business development initiatives for the CTT unit (i.e., prepare and perform demos, create presentation materials).
• 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, including peer‑review and verification of CTT deliverables and outputs.

QUALIFICATIONS :