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Global Study Manager

4 months ago

Mississauga, Canada AstraZeneca Full time

**Global Study Manager, 12 Month Contract**

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

**Minimum 1 day from our Mississauga office and 2 days from our Mississauga or Downtown 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.

**What you’ll do**:

- In partnership with AZ team, other AZ clinical experts and external service providers, the GSM provides oversight to ensure study delivery.
- Leads/contributes to the preparation of delegated study documents (e.g., Informed Consent Form, master Clinical Study Agreement etc), and external service provider related documents (specifications, study specific procedures, descriptions, presentations etc.).
- Maintains and facilitates interactions with internal functions and external functions including the CROs and other external service providers to ensure an efficient study delivery to time, costs and quality objectives.
- Contributes to the planning and conduct of internal and external meetings (e.g., Investigators’/Monitors’ meeting).
- Ensures the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers as appropriate.
- Proactively contributes to risk and issue identification, development of mitigation and/or action plans for identified risks and issues.
- Ensures that all study documents in scope of GSM’s responsibilities are complete and verified for quality in Trial Master File.
- Supports GSD and/or GSAD with budget management, such as external service provider invoice reconciliation.
- Adheres to global clinical processes, procedural documents, applicable Quality & Compliance manual documents and international guidelines such as ICH/GCP to ensure study is inspection ready at all times.
- Supports GSD and/or GSAD with overall project management as per agreed delegation.
- For outsourced studies, supports GSD and/or GSAD in management of the CRO Project Manager to ensure study delivery according to agreed timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with Internal relevant AZ SOPs and guidelines (e.g., description of services and transfer of obligations)
- Take on assignments on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager

**Essentials for the role**:

- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
- Minimum 3 years experience within the pharmaceutical industry supporting clinical operations
- Shown project management, organizational and analytical skills
- Knowledge of clinical development / drug development process across various phases and therapy areas as well as relevant knowledge of international guidelines ICG-GCP
- Computer proficiency
- Excellent knowledge of spoken and written English

**Great People want to Work with us Find out why**:

- GTAA Top Employer Award for 10 years
- Top 100 Employers Award
- Canada’s Most Admired Corporate Culture
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