Centralized Monitor

Kirkland, Canada | Full time | Home-based | R1552964

To be eligible for this position, you must reside in the same country/commercial region where the job is located

Location: Canada, Remote

Job Overview

Manage the execution of assigned clinical studies from start to finish. Ensure that the management of clinical studies and project deliverables are completed on schedule and in accordance with standardized operating procedures (SOPs), policies, and established practices. Provide support and assistance related to projects across multiple projects, sites, and teams, and review structured clinical data with access to medical records. Ensure that work is performed in accordance with SOPs, policies, clinical best practices (CBPs), and applicable regulatory requirements. Ensure that the protocol, overall completeness, and readiness of patient information are maintained for the next level of review, while adhering to performance indicators and timelines.

Facilitate an effective review of site visit reports and ensure the uniform application of quality standards to meet or exceed established standards. Ensure the safety of participants, data integrity, problem escalation, and the rapid and appropriate transmission of feedback, in accordance with IQVIA's SOPs, International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines, protocol requirements, and regulatory requirements.

Develop and use study management plans, risk-based monitoring tools and models, and other study-specific plans to assess the quality and integrity of studies. Support the project management team in developing monitoring strategies, including the definition of triggers and monitoring thresholds. Monitor the operational progress of assigned projects and perform trend analyses of study/site indicators (analysis of trial's clinical aspects trends, communication of trends, development and tracking of action plans, examination, triage and management of clinical study alerts, monitoring of compliance with Clinical Operations Plan [COP], etc.).

Essential Functions

• Manage assigned sites and perform Subject Level Data Reviews autonomously; if necessary, assume both responsibilities in a dual role.
• Conduct remote monitoring visits for assigned sites.
• Perform Subject Level Data Reviews requiring additional investigation at the clinical site to determine overall accuracy (inclusion and exclusion criteria, investigational product [IP], adverse events [AE], laboratory results, end of treatment [EOT], end of study [EOS], assessment criteria, serious adverse events [SAE], etc.). Review any other relevant information to assess the readiness of the participant's file for the next level of review.
• Perform study-specific analyses in accordance with applicable plans. Contribute to the development of new analytical proposals as needed by clients and be able to write analytical interpretations adding value.
• Monitor the operational progress of assigned sites and studies and perform trend analyses of study/site indicators (analysis of trial's clinical aspects trends, communication of trends, development of action plans, management of clinical alerts, monitoring of compliance with COP, etc.).
• Provide, under supervision, contributions to clinical study teams, key decision-makers, and internal team members to support continuous process improvement, issue escalation, and workload forecasting.
• Identify the added value of centralized review and remote monitoring in studies and provide recommendations to relevant stakeholders.
• Support CMS managers in supervising the clinical deliverables of assigned projects in accordance with the protocol, SOPs, regulations, applicable guidelines, and Clinical Operations Plan.
• Collaborate with project resources and provide support (ARC/CRA, CTA, and centralized monitoring team).
• Ensure complete and accurate documentation of all site-specific tools and models and keep sites ready for audit.
• Perform centralized monitoring activities for assigned sites and evaluate their quality and integrity in accordance with the protocol, SOPs, regulations, and applicable guidelines.
• Ensure the accuracy and updating of internal systems, databases, tracking tools, and reports related to site-specific information.
• Manage triggers and prepare i-Site kits for concerned sites and countries within the framework of assigned studies.
• Perform delegated activities and/or act as a substitute for relevant stakeholders within the project team.
• Conduct periodic reviews of key risk indicators (KRI) at the site level and their historical performance in accordance with the Centralized Monitoring Plan, and provide recommendations to CMS managers to facilitate early identification of risks and issues.
• Monitor site performance and recommend timely corrective measures (e.g., telephone contact with the site or triggered on-site monitoring visit).
• Evaluate the effectiveness of recommended measures and take additional appropriate measures when expected results are not observed.
• Work in accordance with the study's Centralized Monitoring Plan.
• Establish and maintain effective communication with relevant project and site stakeholders.
• Provide mentorship to Associate Centralized Monitors.
• Review reports in accordance with annotations, SOPs, and guidelines; identify issues, report them to the clinical lead, prepare annotations, provide training to ARCs, and hold monthly meetings with stakeholders to discuss the main issues and trends observed.
• Act as a technical solutions specialist (TSS) and resource person for project teams and internal stakeholders to gather criteria and requirements.
• Analyze the complexity of requirements and provide effort estimates (EAC) and completion timelines.
• Review the study's Centralized Monitoring Plan.
• Participate in kick-off meetings, weekly team meetings, and client meetings as needed.
• Comply with the key activities described in the Statement of Work (SOW) in accordance with client requirements.

Qualifications

• Bachelor's degree in clinical sciences, life sciences, mathematical sciences, or a related field, or a nursing degree.

Requirements

• Minimum of two (2) years of relevant professional experience or equivalent combination of education, training, and experience.
• New graduates with a medical degree or in a related paramedical field may also be considered.
• Clinical research experience is an asset.
• The required level of experience may vary depending on the specific requirements of clients.
• In-depth knowledge of conducting clinical trials and ability to apply applicable regulatory requirements to clinical research.
• Knowledge of International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines as well as local laws, regulations, and guidelines applicable to clinical trials.
• Good knowledge of clinical systems.
• Excellent written and verbal communication skills, including good English proficiency.
• Results-oriented approach and attention to detail in performing work and producing deliverables.
• Understanding of clinical and medical data.
• Good motivational, influential, and coaching skills.
• Ability to work on multiple projects simultaneously and manage competing priorities.
• In-depth knowledge of therapeutic areas and protocols.
• Excellent organizational and problem-solving skills.
• Strong presentation skills.
• Demonstrated ability to deliver results in accordance with quality requirements and deadlines.