Role Description 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. - 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, including daily checks of automated data queries and 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. - Monitor all studies involved with CTT to ensure accuracy and quality of the data, including the development of SAS checks for CTT applications. - 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, 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. - 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. - 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. - 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. Qualifications - A bachelor's 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. - Adaptive to varying customer knowledge and skill levels. - Adhere to all company security and privacy standards, and other policies and SOPs. - Good organizational skills and the ability to handle multiple tasks. Benefits - Robust benefits package including medical, dental, and vision coverage. - Life & AD&D insurance. - Short- and long-term disability. - Tuition reimbursement. - Fitness reimbursement. - Employee assistance program (EAP). - Pension plan. - Generous paid time off and sick leave. - Opportunity to earn a performance-based bonus.

Role Description 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. - 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, including daily checks of automated data queries and 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). - 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 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. - Provide analytical, report generation, and project execution support to CTT and Everest management team members for internal CTT capability development initiatives. Qualifications - A Bachelors’ degree in health science, physical or biological fields. - At least 3 years’ experience in clinical trial data processing and management. - Education or experience must demonstrate the ability to work independently. - Clear, professional and energetic telephone voice. - Detailed approach to data review and system development. Benefits - Robust benefits package to support health, well-being, and growth. - Medical, dental, and vision coverage. - Life & AD&D insurance. - Short- and long-term disability. - Tuition reimbursement. - Fitness reimbursement. - Employee assistance program (EAP). - Pension plan. - Generous paid time off and sick leave. - Opportunity to earn a performance-based bonus. Company Description 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. Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. 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.

Role Description 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. This is a full‑time, permanent position providing overnight support, Sunday through Friday, from 11:00 p.m. to 7:00 a.m. - 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, including: - Daily checks of automated data queries built in the CTT applications. - 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) in a systematic and 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 - A Bachelors’ degree in health science, physical or biological fields. - At least 3 years’ experience in clinical trial data processing and management. - Education or experience must demonstrate the ability to work independently. - Clear, professional and energetic telephone voice. - Detailed approach to data review and system development. Benefits - Robust benefits package to support health, well-being, and growth. - Medical, dental, and vision coverage. - Life & AD&D insurance. - Short- and long-term disability. - Tuition reimbursement. - Fitness reimbursement. - Employee assistance program (EAP). - Pension plan. - Generous paid time off and sick leave. - Opportunity to earn a performance-based bonus. Company Description 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 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.

Role Description 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 Clinical Research Safety Associate 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. - Serve as the DMC Secretary and perform hands-on administrative tasks for assigned projects, according to Everest’s SOPs. - Assist with the identification, recruitment, and engagement of committee members, including contract negotiations, consultant agreements, and administration of honorarium payments. - Serve as the liaison between the committee and the sponsor. - Write the committee Charter and its amendments and circulate for their review, finalization, and sign-off by the committee and Sponsor. - Assist with coordinating the preparation of the committee Data Reports by external or internal statistical programming teams and the delivery of the Data Reports and other deliverables to the committee members, according to the Charter. - Plan, schedule, and coordinate all committee meetings, produce meeting minutes, and assist the DMC Chair with the Recommendations Letter, according to the Charter. - Support project management of DMC area with activities focused on planning and execution of DMC administration tasks and biostatistical support for these committees for assigned projects. - Manage the planning, implementation, conduct, and reporting of assigned projects within the established timelines and budgets, with high quality and meeting regulatory requirements. - Coordinate activities between Everest and trial sponsors, and with various supporting groups or vendors when necessary. - Support medical writing and clinical safety monitoring teams by performing quality control (QC) review of document deliverables. - Under supervision, perform medical writing tasks, including writing of simple clinical study reports, simple study protocol, and other regulatory documents. - Perform data verification (QC) on statistical programming outputs against data sources. - Perform consistency review of document formats, styles, and overall layout according to a document style guide. - Learn and perform document e-publishing for clinical trial and regulatory documents. - May assist with case processing of safety events (SAE and/or pregnancy reports) from clients’ ongoing drug clinical trials. - Keep current on the training of Everest Guidance Documents and with the general requirements or guidelines issued by the pharmaceutical drug trial regulators and ICH. Qualifications - M.Sc. or Ph.D. in a clinical or medical or health-related field. - At least two years' clinical research experience in an academic, pharmaceutical, or CRO environment. - Experience in Phase I through Phase IV clinical trials with knowledge of drug/medical device regulations and industry standards. - Experience with an accepted clinical data capture and management system (preferred). - Strong verbal and written communication skills with the ability to understand and summarize medical terminology. - Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines. - Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data. - Detail-oriented, customer- and quality-focused. - Excellent interpersonal and teamwork skills. - Computing skills in MS Office applications (preferred). - Proven flexibility and adaptability when working in a team and independently, using good judgment in making decisions (preferred). Benefits - Robust benefits package including medical, dental, and vision coverage. - Life & AD&D insurance. - Short- and long-term disability. - Tuition reimbursement. - Fitness reimbursement. - Employee assistance program (EAP). - Pension plan. - Generous paid time off and sick leave. - Opportunity to earn a performance-based bonus. - Estimated Salary Range: $60,000 - $85,000.