This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description This role offers a dynamic opportunity to contribute to campaign planning, market research, and cross-functional support in a fast-paced, collaborative environment. - Help the Deal Desk Manager with various tasks - Perform analysis and spreadsheet-based analytics to help the sales team determine and secure the campaign criteria, deliverable volumes, and pricing - Perform research on upcoming proposals, market trends, products, and service provisions to better understand clients’ needs - Make suggestions on upcoming and current campaign strategies - Perform other duties as assigned Qualifications - Uncompromising attention to detail and accuracy - Excellent organizational and planning skills - Great analytical skills - Ability to work on multiple projects simultaneously, many under tight deadlines - Extremely flexible and adaptive to changing circumstances - Excellent communication skills Company Description INFUSE is a global B2B demand generation company supporting top tech brands with data-driven marketing solutions.

• Monitors clinical trials and observational studies ensuring protocol adherence, managing site activities, and overseeing data collection and integrity. • Ensures sites are conducting the study(ies) and reporting study data as required by applicable regulations and guidelines, and sponsor requirements. • Thorough knowledge and application of project specific protocol. • Performs remote and on-site monitoring in accordance with project specific timelines. • Completes travel scheduling in accordance with project specific and UBC travel policy. • Submits expense reports within UBC requirements. • Attends project team meetings, department meetings and one-to-one meetings with the manager. • Completes site monitoring reports and letters per UBC and/or sponsor SOPs requiring minimal corrections. • Ensures follow-up of site issues and action items per UBC/sponsor timelines. • Enters site visits, site monitoring reports, follow up letter sent date and site contacts into Clinical Trial Management System (CTMS). • Monitors within Electronic Data Capture (EDC) data entry, if applicable, and assists sites with electronic Case Report Form (eCRF) resolution. • Reviews Investigator Site File and performs Investigational Product reconciliation. • Maintains regular contact with assigned sites per study requirements. • Completes all SOP review, training assessments and documentation within requested timelines. • Travel up to 50% required in the European region. • Travel up to 80% required in the North American region. • Completes Site Management and Monitoring activities in accordance with project specific plans and timelines. • Assists with other duties as assigned, which may align with other departments at UBC.

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance • Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate • Demonstrates diligence in protecting the confidentiality of each subject/patient • Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues • Conducts Source Document Review of appropriate site source documents and medical records • Verifies required clinical data entered in the case report form (CRF) is accurate and complete • Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines • Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture • Verifies site compliance with electronic data capture requirements • May perform investigational product (IP) inventory, reconciliation and reviews storage and security • Verifies the IP has been dispensed and administered to subjects/patients according to the protocol • Verifies issues or risks associated with blinded or randomized information related to IP • Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness • Reconciles contents of the ISF with the Trial Master File (TMF) • Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan • Supports subject/patient recruitment, retention and awareness strategies • Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution • For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met • Must be able to quickly adapt to changing priorities to achieve goals / targets • May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings • Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions • Knowledge of local requirements for real world late phase study designs • Chart abstraction activities and data collection • Collaboration with Sponsor affiliates, medical science liaisons and local country staff

• Performs and coordinates all aspects of the clinical monitoring and site management process. • Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. • Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). • Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. • Ensures audit readiness. • Develops collaborative relationships with investigational sites. • Monitors investigator sites with a risk-based monitoring approach.