Introduction
The Medical Evidence team at AstraZeneca Canada is comprised of Evidence Delivery and Evidence Generation. This team is responsible for leading the local management of AstraZeneca (AZ) 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., AZ Standard Operating Procedures [SOPs]) to deliver studies that meet time, cost, and quality objectives. This person will also serve as the main liaison between AZ and Principal Investigators and their study teams (e.g., academic and research organizations).
Responsibilities
- Support 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 AZ Global, AZ 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 stakeholders
- Set 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 trials
- Input regular updates into the internal study Excel trackers and support with monthly set up
- Lead 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 needed
- Supporting the drafting and execution of research agreements and amendments
- Fill out forms to retrieve key information including LoA and WBS requests
- Support with adverse event reconciliation may include consultation with Patient Safety
- Obtain 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 used
- Submit 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 iEnvision system and provide any follow up information requested by the Publication Coordinators
Requirements
- Bachelor’s in science degree at a minimum but Master’s or doctorate level preferred
- Experience 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 strong communication to influence or align stakeholders and foster collaboration, and advance initiatives through the organization
- Experience working alongside busy clinician scientists, asset if experience serving as a liaison of a pharmaceutical company
- Self-motivated and able to display autonomy and initiative; for instance, able to make decisions/ move actions forward without continual supervision or consultation
- Effective time management, prioritization, and organization and attention to detail to manage a dynamic and fast-paced changing environment
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