Evidence Delivery Associate/Manager, Medical Evidence Canada
Canada, Ontario, Mississauga
Fulltime: 37.5 hrs a week / CA$ 51 - 64 per hour
Experience: From 2 years
Pharmaceuticals
Introduction
Evidence Delivery Associate/Manager, Medical Evidence Canada (12-month contract)Mississauga, ON - Hybrid
What are you going to do
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
Essential skills and knowledge
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
What we offer
What We Offer
Why apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. We'll get you going while you get on with the job.
About Us
Brunel 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.