Evidence Delivery Associate/Manager, Medical Evidence Canada (Mississauga)

Evidence Delivery Associate/Manager, Medical Evidence Canada (Mississauga)

01 Nov
|
Brunel
|
Mississauga

01 Nov

Brunel

Mississauga

The Medical Evidence team is comprised of Evidence Delivery and Evidence Generation. This team is responsible for leading the local management of the clients sponsored real-world evidence (RWE) and externally sponsored research (ESR) studies. The Evidence Delivery function within the Medical Evidence Canada Team is responsible for the strategic and efficient delivery of ESR studies. The Evidence Delivery Manager, Medical Evidence will lead the delivery and oversight of ESR studies in the assigned therapeutic area. Assigned studies may span multiple therapeutic areas in the Oncology Business Unit (OBU) and Biopharmaceuticals Business Unit (BBU).Reporting to the Director, Medical Evidence in Canada, the incumbent will work closely with the other Evidence Delivery Managers and in a cross-functional environment. Internal stakeholders include but not limited to Medical Affairs (e.G., Medical Advisor), Drug Supply, Regulatory, Patient Safety, Legal, Finance, and ESR Governance and Operations. This role involves collaboration with these teams to ensure adherence to all relevant policies and processes (e.G., Standard Operating Procedures (SOPs)) to deliver studies that meet time, cost, and quality objectives. This person will also serve as the main liaison between the client and Principal Investigators and their study teams (e.G., academic and research organizations).ResponsibilitiesSupport the initial triage checklist and proposal cross-functional review by evaluating the operational feasibility (e.G., availability of funds and drug supply)Following study approval, serve as the main point of contact between Global, local,



and the Institution (including but not limited to the Principal Investigator and study team)Coordinate the initial protocol review and subsequent protocol amendments with the relevant stakeholdersSet up and maintain the study in Veeva Clinical Vault (e.G., upload files, enter information into fields, performance assessments)Distribution of IBs to Investigators for interventional trialsInput regular updates into the internal study Excel trackers and support with monthly set upLead the drafting and executing of confidentiality disclosure agreements, supporting administrative finalization of legal documents (e.G., accepting track changes, deleting comments), and consulting with Legal as neededSupporting the drafting and execution of research agreements and amendmentsFill out forms to retrieve key information including Lo A and WBS requestsSupport with adverse event reconciliation may include consultation with Patient SafetyObtain and/or complete necessary documentation for drug supply and submit order documents (e.G., drug order forms, supply plan)Schedule and facilitate meetings — take minutes for meetings where transcript is not usedSubmit invoices, enter information into the ABACUS accounting system, update internal budget tracker,



and communicate any budget issues/changes with the relevant stakeholders (e.G., Finance Business Partner, Senior Marketing Manager)Submit publications for review using the i Envision system and provide any follow up information requested by the Publication CoordinatorsRequirementsBachelor’s in science degree at a minimum but Master’s or doctorate level preferredExperience in project management and/or clinical study management (e.G., operations and study design of clinical trials, drug development process in Canada, and relevant research guidelines (e.G., GCP/ICH))Demonstrated success in building rapport and navigating cross-functional matrixed environments by leveraging robust communication to influence or align stakeholders and foster collaboration, and advance initiatives through the organizationExperience working alongside busy clinician scientists, asset if experience serving as a liaison of a pharmaceutical companySelf-motivated and able to display autonomy and initiative; for instance, able to make decisions/ move actions forward without continual supervision or consultationEffective time management, prioritization, and organization and attention to detail to manage a dynamic and quick-paced changing environmentAbout UsBrunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.#J-18808-Ljbffr

📌 Evidence Delivery Associate/Manager, Medical Evidence Canada (Mississauga)
🏢 Brunel
📍 Mississauga

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