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Senior Clinical Trial IWRS Operations Manager

2 months ago

Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time
About the Role

We are seeking a highly skilled and experienced Senior Clinical Trial IWRS Monitor to join our team at Everest Clinical Research Services Inc. As a key member of our Clinical Trials Technology (CTT) unit, you will play a critical role in ensuring the accuracy and quality of data generated within our IWRS/IRT and eDiary systems.

Key Responsibilities
  • Client Relationship Management: Act as a lead and primary contact with clients, building and maintaining relationships through work deliveries, solution designs, issue resolution, and escalations.
  • CTT User Support: Act as primary contact with CTT Users for the Everest IWRS/IRT and eDiary team via the CTT Helpdesk telephone or Helpdesk email accounts.
  • Issue Analysis and Resolution: 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.
  • Drug Management Analysis: Perform medium-complexity drug management analysis and forecasting as required to ensure site and study drug inventory is managed effectively.
  • Data Monitoring: 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.
  • Change Control: Coordinate and verify changes to the database and application using appropriate change control procedures, ensuring comprehensive and accurate documentation is completed.
  • Escalation Point: 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).
  • Study Monitoring: 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.
  • Risk Management: Manage risks, issues, and escalations and work with teams in identifying mitigation/remediation options.
  • Quality Control: 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.
  • Client Service: Provide excellent client service and support during start-up activities, demonstrating subject matter knowledge and providing guidance and advice on solution designs and processes.
  • Documentation: Generate, maintain, and/or review CTT Requirements Specification documents.
  • Testing: Develop CTT study test plans for newly developed projects or perform User Acceptance Testing (UAT) on newly developed projects with CTT.
  • Application Testing: 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).
  • Quick Reference Guides: Generate, maintain, and/or review Quick Reference Guides for all CTT studies.
  • Demonstrations: Conduct IWRS demonstrations to Sponsors, as well as training demonstrations to study team members.
  • Communication: Support communications and coordination with Sponsors, Study Team Members, Depot personnel, and internal Everest data management and statistical leads across the CTT development lifecycle.
  • QA Support: Drive, collaborate, and support, when required, data management, quality assurance (QA) personnel in performing QA procedures on CTT applications.
  • Trend Analysis: 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.
  • Project Support: Provide analytical, report generation, and project execution support to CTT and Everest management team members for internal CTT product/capability development initiatives.
  • Business Development: Lead and support ad hoc business development initiatives for the CTT unit (i.e., prepare and perform demos, create presentation materials).
  • SOP Development: Drive, develop, and recommend the development of new CTT-related SOPs, processes, and procedures.
  • Training and Mentoring: Train, manage, and mentor junior CTT monitors on monitoring and training activities, including peer-review and verification of CTT deliverables and outputs.
Requirements
  • Education: A bachelors' degree in health science, physical or biological fields, or computer science.
  • Experience: At least five years of experience in clinical trial data processing and management.
  • Skills: 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.