Study Delivery Associate

The Study Delivery Associate assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives.

**Your responsibilities include**:

- Assists in coordination and administration of clinical studies from the start-up to execution and close-out.
- Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.
- Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements.
- Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”.
- Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.
- Contributes to the production and maintenance of study documents, ensuring template and version compliance.
- Creates and/or imports clinical-regulatory documents into the Global Electronic Management System (e.g. ANGEL) ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents.- Sets-up, populates and accurately maintains information in AstraZeneca tracking and communication tools (e.g. CTMS such as VCV, SharePoint, etc) and supports others in the usage of these systems (with the exception of countries where there is a specific role dedicated to set up and update the systems).
- Prepares and/or supports contract preparation at a site level (with the exception of countries where there is a specific role dedicated to preparing site contracts).
- Prepares/supports/performs Health Care Organisations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations.
- Manages and contributes to coordination and tracking of study materials and equipment.
- Coordinates administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs.
- Leads the practical arrangements and contributes to the preparation of internal and external meetings e.g., study team meetings, Monitors’ meetings, Investigators’ meetings. Liaises with internal and external participants and/or vendors, in line with international and local codes.
- Interfaces with Data Management Centre and/or Data Management, Global Clinical Solutions representatives to facilitate the delivery of study related documents/material.

**Your qualifications include**:

- University degree in Health Science, or a related field (an equivalent combination of education, training, and work experience may be considered
- 1 year of experience in Clinical Research or related industry
- Understanding of Good Clinical Practices/International Committee on Harmonization principles
- Strong social and interpersonal skills (written and oral). You will be confident speaking to Health Care Professionals.
- You are self-motivated and able to display autonomy and initiative
- You seek multiple demands/projects simultaneously
- Effective time management skills
- Your passion lies in customer service
- Being bilingual in French would be considered an asset.
- Previous administrative experience preferably in the medical/ life science field.

**AstraZeneca Canada**

**WHY JOIN US?**

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.

**SO, WHAT’S NEXT?**

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

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