Senior Clinical Trial IWRS Monitor

2 days ago

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

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:

A bachelors' 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 Trials Specialist

    3 days ago

    Toronto, Ontario, Canada ICON Full time

    At ICON, we're committed to providing exceptional patient care and advancing the field of clinical research.Job Description:We're seeking a skilled Clinical Research Associate to join our team. As a CRA, you'll play a critical role in ensuring the success of our clinical trials by overseeing multiple oncology trials, providing leadership and mentorship to...

  • Oncology Trials Specialist

    18 hours ago

    Toronto, Ontario, Canada Pharmaceutical Research Associates, Inc Full time

    About UsWe are Pharmaceutical Research Associates, Inc., a leading clinical research organization powered by healthcare intelligence. Our team of experts is dedicated to delivering high-quality results in the pharmaceutical industry.The RoleWe are seeking a skilled Clinical Research Associate to join our team. As a CRA, you will be responsible for overseeing...

  • Senior Clinical Trials Manager

    5 days ago

    Toronto, Ontario, Canada ICON Full time

    Job DescriptionWe are looking for a highly skilled Senior Clinical Trials Manager to join our team at ICON. This role will involve overseeing the execution of multiple oncology trials, while providing guidance and support to junior colleagues.Key Responsibilities- Develop and implement effective risk-based/analytical monitoring approaches- Collaborate with...

  • Clinical Operations Manager

    2 days ago

    Toronto, Ontario, Canada ICON Full time

    ICON is a leading provider of clinical research services, and we're looking for a talented Clinical Research Associate to join our team.Role Summary:As a CRA, you'll be responsible for overseeing multiple oncology trials, developing study protocols, and collaborating with investigators and site staff to meet study timelines.Our team is dedicated to...

  • Senior Clinical Trial Drug Safety Associate I

    7 days ago

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

    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...

  • clinical trial assistant

    5 days ago

    Toronto, Ontario, Canada i-Pharm Consulting Full time

    Job Title: Clinical Research Associate (CRA) II/Senior CRA Job Type: Permanent Full Time Must Have: Minimum 2 Years of On Site Monitoring Experience & 1 Year of Oncology Experience Our client is a global leader in healthcare data, technology, and advanced analytics, dedicated to supporting the pharmaceutical and biotechnology industries in the development...

  • Senior Lead Clinical Trials Specialist

    1 day ago

    Toronto, Ontario, Canada Ecrscorp Full time

    Ecrscorp is a global leader in contract research organizations (CROs), providing expertise-based clinical research services to pharmaceutical, biotechnology, and medical device industries. Our company mission is to deliver exceptional results through teamwork and innovative approaches. We are now seeking a seasoned Senior Lead Clinical Trials Specialist to...

  • Clinical Research Associate

    4 weeks ago

    Toronto, Ontario, Canada ICON Strategic Solutions Full time

    As a CRA you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Oversee multiple oncology trials, ensuring high-quality execution Provide leadership and mentorship to junior flex team members Act as Lead SM, training and guiding other Site Managers on study protocols Represent Site...

  • Site Management Specialist in Clinical Trials

    3 days ago

    Toronto, Ontario, Canada i-Pharm Consulting Full time

    Role Overviewi-Pharm Consulting is seeking a Senior Clinical Research Associate II (CRA II) to join our team and contribute to the success of our oncology clinical trials. As a CRA II, you will be responsible for overseeing and managing the progress of clinical trials at investigational sites.You will ensure adherence to the study protocol, ICH-GCP, and...

  • Clinical Research Manager

    22 hours ago

    Toronto, Ontario, Canada Pharmaceutical Research Associates, Inc Full time

    OverviewWe are seeking a highly experienced Clinical Research Associate to join our team at Pharmaceutical Research Associates, Inc. This role is responsible for overseeing multiple oncology trials, ensuring high-quality execution and providing leadership and mentorship to junior flex team members.ResponsibilitiesOversee multiple oncology trials, ensuring...

  • Clinical Trial Manager

    5 days ago

    Toronto, Ontario, Canada Parexel Full time

    When our values align, there's no limit to what we can achieve.   Job Summary: The Clinical Trial Manager (CTM) is accountable for the operational and scientific oversight, the set-up, execution and delivery of their assigned clinical trials at the regional/local level. CTMs contribute to delivery of the pipeline through accurate planning and...

  • Global Clinical Trials Coordinator

    3 days ago

    Toronto, Ontario, Canada ICON Strategic Solutions Full time

    **Job Summary**Join our dynamic team as a Clinical Research Associate and play a vital role in delivering high-quality clinical trials within Oncology. As a key member of our global clinical trials team, you will be responsible for monitoring and coordinating trials, mentoring junior team members, and working closely with our country budget development...

  • Senior Oncology Clinical Trial Manager

    4 days ago

    Toronto, Ontario, Canada i-Pharm Consulting Full time

    About the Rolei-Pharm Consulting is dedicated to supporting the pharmaceutical and biotechnology industries in the development of life-changing therapies. We are seeking a highly skilled Clinical Research Associate II (CRA II) to join our team and contribute to the success of cutting-edge oncology clinical trials.As a CRA II, you will be responsible for...

  • 3 Days Left) Clinical Research Associate

    1 day ago

    Toronto, Ontario, Canada Pharmaceutical Research Associates, Inc Full time

    OverviewAs a CRA you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.ResponsibilitiesWhat you will be doing:- Oversee multiple oncology trials, ensuring high-quality execution- Provide leadership and mentorship to junior flex team members- Act as Lead SM, training and guiding other...

  • Clinical Research Associate I/II

    2 weeks ago

    Toronto, Ontario, Canada ICON Strategic Solutions Full time

    As a CRA you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.What you will be doing:Oversee multiple oncology trials, ensuring high-quality executionProvide leadership and mentorship to junior flex team membersAct as Lead SM, training and guiding other Site Managers on study...

  • Clinical Research Associate I/II

    2 weeks ago

    Toronto, Ontario, Canada ICON Strategic Solutions Full time

    As a CRA you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.What you will be doing:Oversee multiple oncology trials, ensuring high-quality executionProvide leadership and mentorship to junior flex team membersAct as Lead SM, training and guiding other Site Managers on study...

  • Clinical Research Associate I/II

    4 weeks ago

    Toronto, Ontario, Canada ICON Strategic Solutions Full time

    As a CRA you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. What you will be doing: Oversee multiple oncology trials, ensuring high-quality execution Provide leadership and mentorship to junior flex team members Act as Lead SM, training and guiding other Site Managers on study...

  • Clinical Research Associate I/II

    4 weeks ago

    Toronto, Ontario, Canada ICON Strategic Solutions Full time

    As a CRA you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. What you will be doing: Oversee multiple oncology trials, ensuring high-quality execution Provide leadership and mentorship to junior flex team members Act as Lead SM, training and guiding other Site Managers on study...

  • Clinical Research Associate I/II

    4 weeks ago

    Toronto, Ontario, Canada ICON Strategic Solutions Full time

    As a CRA you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. What you will be doing: Oversee multiple oncology trials, ensuring high-quality execution Provide leadership and mentorship to junior flex team members Act as Lead SM, training and guiding other Site Managers on study...

  • Senior Site Manager

    14 hours ago

    Toronto, Ontario, Canada Pharmaceutical Research Associates, Inc Full time

    Clinical Research AssociatePharmaceutical Research Associates, Inc. is seeking a highly motivated and experienced Clinical Research Associate to join our team. As a CRA, you will be responsible for overseeing multiple oncology trials, ensuring high-quality execution and providing leadership and mentorship to junior flex team members.Job SummaryOversee...