Everest Clinical Research Services Inc.
Senior Clinical Trial IWRS Monitor I
Everest Clinical Research Services Inc., Trenton, New Jersey, United States,
Job Category : Clinical Trial TechnologiesRequisition Number : SENIO002143Apply nowPosted: July 16, 2024Full-TimeLocations
Showing 1 locationEverest 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.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 a
Senior Clinical Trial IWRS Monitor
for our Brightech location in
Taipei, Taiwan
with opportunities to work remotely 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, including daily checks of automated data queries and weekly manual checks of data.Coordinate and verify changes to the database and application using appropriate change control procedures, ensuring comprehensive and accurate documentation.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 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 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).Execute CTT application test planning, test plan and test script development, and testing activities for CTT applications.Generate, maintain, and/or review Quick Reference Guides for all CTT studies.Conduct IWRS demonstrations to Sponsors and training demonstrations to study team members.Support communications and coordination with Sponsors, Study Team Members, and internal Everest data management and statistical leads across the CTT development lifecycle.Drive, collaborate, and support QA personnel in performing QA procedures on CTT applications.Analyze CTT monitoring and support trends to identify new CTT core features to improve efficiency and effectiveness.Provide analytical, report generation, and project execution support 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 critically and apply problem-solving skills.Ability to effectively interact with clients and internal staff.At least four years of experience in clinical trial data processing, technology delivery, process analysis and design.Experience with client relationship management.Comfortable using web application technologies and has prior customer service/support experience.Excellent communication skills that provide an exceptional customer service experience.Aptitude to learn and retain CTT application rules and support procedures.Good organizational skills and the ability to handle multiple tasks.We thank all interested applicants; however, only those selected for an interview will be contacted.Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request, we will provide accommodations for candidates participating in any part of our recruitment and selection process.
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Showing 1 locationEverest 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.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 a
Senior Clinical Trial IWRS Monitor
for our Brightech location in
Taipei, Taiwan
with opportunities to work remotely 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, including daily checks of automated data queries and weekly manual checks of data.Coordinate and verify changes to the database and application using appropriate change control procedures, ensuring comprehensive and accurate documentation.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 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 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).Execute CTT application test planning, test plan and test script development, and testing activities for CTT applications.Generate, maintain, and/or review Quick Reference Guides for all CTT studies.Conduct IWRS demonstrations to Sponsors and training demonstrations to study team members.Support communications and coordination with Sponsors, Study Team Members, and internal Everest data management and statistical leads across the CTT development lifecycle.Drive, collaborate, and support QA personnel in performing QA procedures on CTT applications.Analyze CTT monitoring and support trends to identify new CTT core features to improve efficiency and effectiveness.Provide analytical, report generation, and project execution support 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 critically and apply problem-solving skills.Ability to effectively interact with clients and internal staff.At least four years of experience in clinical trial data processing, technology delivery, process analysis and design.Experience with client relationship management.Comfortable using web application technologies and has prior customer service/support experience.Excellent communication skills that provide an exceptional customer service experience.Aptitude to learn and retain CTT application rules and support procedures.Good organizational skills and the ability to handle multiple tasks.We thank all interested applicants; however, only those selected for an interview will be contacted.Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request, we will provide accommodations for candidates participating in any part of our recruitment and selection process.
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