Global Study Associate – 12 Month ContractAstraZeneca seeks a Global Study Associate to support delivery of clinical studies within BioPharmaceuticals Clinical Operations.ResponsibilitiesSupport GS(A)D and GSMs by completing delegated study work, potentially across multiple studies and delivery models concurrently.Initiate and lead the set‑up of the electronic Trial Master File (eTMF) and maintain it through close‑out to ensure compliance with ICH‑GCP and AstraZeneca SOPs.Collect and manage regulatory and other essential documents, collaborating with internal staff and external stakeholders.Create and manage clinical regulatory documents in ANGEL, ensuring technical standards are met for effective submission to regulatory authorities.Plan and collate administrative appendices for the CSR.Generate study documents, ensuring template and version compliance per study requirements.Populate and maintain information in AstraZeneca tracking and communication tools, and assist team members in using these tools.Set up, maintain and close out Clinical Trial Transparency (CTT) activity in PharmaCM, coordinating with stakeholders to fulfill compliance.Track, reconcile and follow‑up study budgets/payments in relevant systems.Coordinate application, coordination, supply and tracking of study materials and equipment; collect study supplies at close‑out if required.Coordinate administrative tasks and logistical support during audits and regulatory inspections, in accordance with company policies and SOPs.Lead arrangements, coordination and preparation of internal and external meetings, including study team meetings,



committee meetings, monitor meetings, investigator meetings and virtual meetings.Prepare, contribute and distribute presentation material for meetings, newsletters and websites.Work on non‑drug project work such as process improvements, or lead improvement projects as agreed with manager.QualificationsEducation in medical or biological sciences or a discipline associated with clinical research.Working knowledge of the Clinical Study Process and understanding of ICH‑GCP guidelines.Bachelor level education (or higher).Experience in the clinical study life cycle.Excellent organization and time‑management skills, with strong attention to detail and ability to multi‑task in a high‑volume environment with shifting priorities.Compensation & BenefitsAnnual base salary: $81,000 to $107,000. Salary is offered within the range based on individual skills and experience. Permanent positions also offer an annual variable pay bonus/short‑term incentive and eligibility for equity‑based long‑term incentive programs. Benefits include a competitive flex benefits and retirement savings program, 4 weeks paid vacation and annual personal days. Fixed‑term contract/temporary positions offer a contract advantages program.Equal Opportunity EmployerAstraZeneca is an equal prospect employer committed to diversity and inclusion, creating a workplace free from discrimination. AstraZeneca accommodates persons with disabilities upon request during the recruitment, assessment or selection process. AstraZeneca may use AI as part of the recruitment process.#J-18808-Ljbffr

📌 Global Study Associate - 12-Month Contract (Mississauga) - C$81,000 - C$107,000 A Year (Winnipeg)
🏢 AstraZeneca
📍 Winnipeg