Study Deliver Associate

1 month ago

Mississauga, Canada AstraZeneca Full time

**Study Delivery Associate**

**Hybrid Work
- on average 3 days/week from office**

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.

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.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

**Our position**

The Study Delivery Associate (SDA) is a key member of our clinical team responsible for managing clinical study trials for patients in Canada. This role will interact with external clinical experts and our internal clinical colleagues to deliver quality clinical trials and provide support and feedback into day-to-day activities.

**What you’ll do**
- Approve sites for drug shipment
- Prepare, execute, track, collect, review and assess clinical documents while ensuring their completeness according to regulatory guidelines
- Assist external investigational site staff with the accurate and timely completion of ethics and regulatory documents in accordance with the regulatory and GCP guidelines
- Review the study scope and design to provide input into the site level activation and risk mitigation plan and give ongoing study/site level problem solving throughout the study
- Support the study lead, by reviewing and contributing to the development and preparation of all study/site level documents as required (for example: Study Management Agreements, delegation of responsibility, Clinical Study Agreements, etc.)
- Support the study regulatory and ethics submission process
- Ensure audit readiness, by conducting quality checks of SMF documents according to the study Quality Control Plan
- Plan and actively collate the appendices for the CS Report
- Develop training material and train site personnel, local study team, research monitors, etc., on study-specific clinical supply and documentation matters (as needed)
- Contribute to the vendor selection and management process where appropriate
- Input and review payment terms and fee schedule of the Clinical Study Agreement.
- Review, assess, approve and process payments associated with Agreements, to be in line with the terms of the agreement and financial guidelines
- Set up and maintain payment terms within the appropriate systems.
- Review, analyze and resolving payment discrepancies and queries
- Lead non-drug supplies, by developing, inputting into, sourcing, ordering, initiating the shipment, tracking, reviewing stock level, and approving materials for destruction
- Handle import shipping approvals
- Prepare and complete Statement of Work (SOW) with vendor for local drug management
- Collaborate with Global Investigational Product Supplies units to ensure precise delivery of clinical drug supplies
- Communicate with global study teams and local regulatory contacts, to assess Canadian requirements for comparator and/or rescue medication, and source from local providers if required
- Review, discuss, and communicate packaging and labelling requirements, as defined by the protocol, with vendors
- Responsible for the notification, investigation and resolution of product quality complaints

**Essentials for the role**:

- University degree in Health Science, or a related field (an equivalent combination of education, training, and work experience may be considered)
- Two years’ 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.
- Ability to influence without authority
- Ability to work effectively both independently and in a team environment
- Self-motivated and able to display autonomy and initiative
- Strong attention to detail with exceptional project management skills
- Effective time management skills
- Passion for customer service
- Good knowledge of MS Office (Word, Excel, PowerPoint) using multiple computer systems
- Bilingualism in French would be considered an asset

**Great People want to Work with us Findout why**:

- GTAA Top Employer Award for 10 years
- Top 100 Employers Award
- Canada’s Most Admir

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