Senior Clinical Trial IWRS Operations Manager

1 month ago

Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time
Job Title: Senior Clinical Trial IWRS Monitor

Everest Clinical Research Services Inc is seeking a highly skilled and experienced Senior Clinical Trial IWRS Monitor to join our team. As a key member of our Clinical Trials Technology (CTT) unit, you will be responsible for providing exceptional customer service and support to our clients and internal stakeholders.

Key Responsibilities:
  • Act as a lead and primary contact with clients, building and maintaining relationships through work deliveries, solution designs, issue resolution, and escalations.
  • Support client requests 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 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 an off-hours escalation point for junior CTT Clinical Monitor resources or the outsourced call center service to resolve high-urgency client requests (based on an 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).
  • 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:
  • 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 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.

  • Clinical Trial IWRS Data Integrity Specialist

    2 weeks ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    About the Role:Everest Clinical Research Services Inc seeks a highly skilled Clinical Trials IWRS System Monitor to join our team in Toronto, Ontario, Canada. As a key member of our IWRS/IRT and eDiary team, you will be responsible for providing exceptional support to our clients and ensuring the accuracy and quality of data generated within our CTT...

  • Clinical Trials IWRS Data Management Specialist

    4 days ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    Everest Clinical Research Services IncWe are a full-service contract research organization (CRO) dedicated to providing high-quality clinical research services to the pharmaceutical, biotechnology, and medical device industries worldwide.Job Description:As a Clinical Trials IWRS Data Management Specialist, you will be responsible for ensuring the accuracy...

  • Clinical Trial Manager

    2 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Senior Clinical Trial LeaderAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies navigate the complex world of clinical trials.We are seeking a Senior Clinical Trial Leader to join our team. As a Senior Clinical Trial Leader, you will be responsible for providing leadership, management, and oversight to Clinical Research...

  • Senior Clinical Data Manager

    4 weeks ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    Job Title: Senior Clinical Data ManagerEverest Clinical Research Services Inc is seeking a highly skilled Senior Clinical Data Manager to join our team. As a Senior Clinical Data Manager, you will be responsible for leading data management activities, performing training, and client relationship management.Key Responsibilities:Develop and maintain Data...

  • Clinical Trials Manager

    4 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Senior Clinical Trial LeaderWe are seeking a highly skilled and experienced Senior Clinical Trial Leader to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and oversight to our Clinical Research Associates (CRAs) and other clinical functional groups in their day-to-day clinical...

  • Clinical Trials Coordinator Lead

    4 days ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    Everest Clinical Research Services Inc, a leading contract research organization (CRO), is seeking an experienced Clinical Trials Coordinator Lead to join our team in Toronto/Markham, Ontario, Canada.Job Summary:As a Clinical Trials Coordinator Lead, you will be responsible for providing exceptional support to clients and internal teams in the delivery of...

  • Clinical Trial Operations Manager

    4 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Job DescriptionWe are seeking a highly skilled and experienced Clinical Trial Operations Manager to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and management to our Clinical Research Associates (CRAs) and other clinical functional groups in their day-to-day clinical trial...

  • Clinical Trials Manager

    4 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Job DescriptionAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are seeking a Senior Clinical Trial Leader to join our team. As a Senior Clinical Trial Leader, you will be responsible for providing...

  • Clinical Trials Leader

    2 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Senior Clinical Trial LeaderWe are seeking a skilled Senior Clinical Trial Leader to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership, management, and oversight to Clinical Research Associates (CRAs) and other clinical functional groups.The ideal candidate will possess a strong...

  • Clinical Trials Operations Leader

    7 days ago

    Toronto, Ontario, Canada Allucent Full time

    About the RoleWe are seeking a skilled Clinical Trials Operations Leader to join our team at Allucent, a dedicated company helping small-medium biopharmaceutical companies navigate the complex world of clinical trials.This senior-level role offers a unique opportunity for an experienced professional to lead and manage clinical research associates (CRAs) and...

  • Clinical Trial Operations Lead

    2 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    About the Role:We are seeking a highly skilled Senior Clinical Trial Leader to join our team at Allucent. As a key member of our organization, you will be responsible for providing leadership and management to our clinical research teams, ensuring the successful execution of clinical trials.Key Responsibilities:Lead and manage clinical research teams,...

  • Clinical Trials Manager

    4 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Job DescriptionWe are seeking a highly skilled Clinical Trials Manager to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and management to our Clinical Research Associates (CRAs) and other functional groups in their day-to-day clinical trial activities.Key...

  • Clinical Trials Manager

    4 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Job DescriptionWe are seeking a highly skilled and experienced Clinical Trials Manager to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and management to our Clinical Research Associates (CRAs) and other clinical functional groups in their day-to-day clinical trial activities.Key...

  • Statistical Director for Clinical Trials

    4 days ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    Job SummaryWe are seeking a skilled Statistical Director to join our team at Everest Clinical Research Services Inc in Bridgewater, New Jersey. As a key member of our Biostatistics department, you will be responsible for managing clinical trial programs and projects from start to finish.

  • Clinical Trials Manager

    4 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Job DescriptionWe are seeking a highly skilled Clinical Trials Manager to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and management to our Clinical Research Associates (CRAs) and other functional groups in their day-to-day clinical trial activities.Key...

  • Clinical Trials Operations Manager

    2 weeks ago

    Toronto, Ontario, Canada Parexel Full time

    Study Operations Manager II Role OverviewThe Study Operations Manager II plays a pivotal role in the success of our clinical trials, driving operational delivery and ensuring the timely execution of study plans. Reporting to the Global Study Managers, this individual will lead specific aspects of the project, driving countries, executing tasks of moderate...

  • Clinical Trials Manager

    4 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Job DescriptionJob Title: Clinical Trials ManagerJob Summary:We are seeking a highly skilled Clinical Trials Manager to join our team at Allucent. As a Clinical Trials Manager, you will be responsible for providing leadership and management to our clinical research associates and other functional groups in their day-to-day clinical trial activities.Key...

  • Senior Clinical Data Manager

    4 weeks ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    Everest Clinical Research Services Inc is a leading contract research organization (CRO) providing comprehensive clinical research services to the pharmaceutical, biotechnology, and medical device industries. We collaborate with top companies and work on cutting-edge drugs, biologics, and medical devices in development.Our organization has a strong...

  • Senior Clinical Data Manager

    4 weeks ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    Everest Clinical Research Services Inc is seeking a skilled Clinical Data Manager to lead data management activities for our clinical trials. The ideal candidate will have a strong understanding of clinical trial data management concepts, processes, and procedures.Key Responsibilities:Develop and maintain Data Management Project Plans.Lead data management...

  • Senior Clinical Data Manager

    4 weeks ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    Everest Clinical Research Services Inc is a leading contract research organization (CRO) providing comprehensive clinical research services to the pharmaceutical, biotechnology, and medical device industries. We serve a diverse range of clients worldwide, working on some of the most advanced drugs, biologics, and medical devices in development today.Our team...