Global Study Associate

4 days ago

Mississauga, Canada AstraZeneca Full time

**Global Study Associate, Oncology (12 Month Contract)**

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 and BlueSky Hub in downtown Toronto are 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 Oncology Research and Development Team**:
Our pioneering approach is identifying and treating patients earlier, focusing on early stage cancer trials and listening and evolving based on their needs. As a team we are deeply committed to transforming the lives of patients living with cancer - with the ultimate aim of eliminating cancer as a cause of death.

**What you’ll do**:

- You will support Global Study Leaders (GSL) and Global Study Associate Managers (GSAMs) by completing delegated study work
- You initiate the set-up, maintain and close the electronic Trial Master File (eTMF) to ensure compliance to International Conference of Harmonization Guidelines for Good Clinical Practice (ICH/GCP) and AZ SOPs
- You will partner with internal functions and external vendors in collection of regulatory and other essential documents
- You will initiate and maintain production of study documents, ensuring template and version compliance per study specific requirements
- You will set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. IMPACT, SharePoint, BOX if used, MS teams and study team shared mailbox) and support team members in the usage of these tools
- You will lead administrative tasks and logistic support throughout the conduct of the study, audits and regulatory inspections, according to company policies and SOPs
- You will oversee and contribute to the preparation of internal and external meetings e.g. study team meetings, committee meetings, monitor meetings, Investigator meetings and virtual meetings. You will liaise with internal and external participants and/or vendors
- You will build and prepare presentation material for meetings, newsletters and web-sites
- You will have the opportunity to provide input into non-drug project work including training activities, and development of procedures as needed
- You are responsible for collecting and reporting Adverse Events in accordance with AstraZeneca policies and SOPs

**Essentials for the role**:

- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research preferred;
- Meaningful clinical experience at administrative level supporting the delivery of clinical trials
- Validated organizational and analytical skills
- Previous administrative training/experience
- Computer proficiency in day-to-day tasks
- Develop working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with clear comprehension of the ICH/GCP guidelines
- Excellent verbal and written communication in English
- Demonstrate ability to work independently, as well as in a team environment
- Ability to prepare presentation materials
- Demonstrate integrity and mutual respect
- Desire and capability to train others on study administration procedures
- Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities

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

- GTAA Top Employer Award for 9 years
- Learn about our culture
- Learn more about working with us in Canada
- View our YouTube channel

AstraZeneca is committed to taking every reasonable precaution to protect employees, our customers and the healthcare systems in the communities in which we serve. In an effort to protect the wellbeing of our employees and customers, full COVID-19 vaccination is an essential requirement of all positions at AstraZeneca. As such, all offers of employment will be conditional upon either (i) proof of full COVID-19 vaccination or (ii) proof of need for accommodation under relevant human rights legislation, and AstraZeneca’s determination that the requested accomm

  • Global Study Associate

    8 months ago

    Mississauga, Canada AstraZeneca Full time

    The Global Study Associate is a member of the extended global study team supporting delivery of clinical studies within BioPharmaceuticals Clinical Operations, Study Management to time, cost and quality. The GSA supports delivery of global clinical studies from study set-up through maintenance, close-out and study archiving. The GSA supports the Global Study...

  • Global Study Associate, Haematology

    2 months ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Associate, Haematology (12 month contract)** **Mississauga, Canada (hybrid work - average of 3 days in 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...

  • Global Study Manager

    3 months ago

    Mississauga, Canada AstraZeneca Full time

    The GSM is a member of extended global study team supporting delivery of clinical studies within Late Development Oncology (LDO) to time, cost and quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR) to study archiving. The GSM works cross-functionally with internal...

  • Global Study Associate Director

    6 months ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Associate Director** **Hybrid Work - 3 days/week from our Mississauga 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...

  • Global Study Associate

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    This is a 12-month contract. The Global Study Associate is a member of the extended global study team supporting delivery of clinical studies within BioPharmaceuticals Clinical Operations, Study Management to time, cost and quality. The GSA supports delivery of global clinical studies from study set-up through maintenance, close-out and study archiving. The...

  • Global Study Manager

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    **Short role description**: The Global Study Manager is a member of the extended global study team supporting delivery of clinical studies within BioPharmaceuticals Clinical Operations, Study Management to time, cost and quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report...

  • Global Study Associate Director, Respiratory and

    4 months ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Associate Director, Respiratory and Immunology** **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 -...

  • Global Study Associate, Smo

    4 weeks ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Associate, SMO** **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...

  • Global Study Director

    6 months ago

    Mississauga, Canada AstraZeneca Full time

    **Exciting Opportunity in Mississauga, Canada: Join Our Team as a Global Study Director (GSD)** Are you ready to play a pivotal role in shaping the future of clinical research? We are seeking a dynamic Global Study Director to lead the planning and delivery of high-priority and complex clinical studies within our BioPharmaceuticals Clinical Operations team....

  • Global Study Associate Director, Respiratory and

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Associate Director, Respiratory and Immunology** **Hybrid Work - 3 days/week from our Mississauga 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...

  • Global Study Associate

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we are guided in our work by a strong set of values, and we’re resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing...

  • Global Study Director Biopharmaceuticals

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    **Locations**: **Barcelona, Spain (on-site)** **Warsaw, Poland (on-site)** **Mississauga, Canada (on-site)*** The Global Study Director (GSD) is a business-critical role within Study Management, BioPharmaceuticals Clinical Operations, whose main accountability is the operational planning and delivery of high priority and complex clinical studies or...

  • Global Study Manager

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    This is a 12-month contract. The Global Study Manager is a member of the extended global study team supporting delivery of clinical studies within BioPharmaceuticals Clincal Operations, Study Management to time, cost and quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report...

  • Global Study Manager

    6 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...

  • Global Study Manager, R&i

    6 months ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Manager, R&I** 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...

  • 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...

  • Global Study Manager, Haematology

    6 months ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Manager, Haematology (CAR-T Program)** **12 Month Contract** **Hybrid Work - 3 days/week from Mississauga 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...

  • Study Delivery Associate

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    **Study Delivery Associate (12 Month Contract)** **Hybrid Work - 3 days a week from our Mississauga, Canada 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...

  • Associate Director Study Data Manager

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    **Job Title: Associate Director Study Data Manager** **Career Level - E** Introduction to Role: Join us as an Associate Director Study Data Manager, where you will be responsible for coordinating the Clinical Data Management (CDM) deliverables on assigned clinical studies. As a member of the Global Study Team (GST), you will be the main point of contact...

  • Global Study Manager, Oncology

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Manager, Oncology** **6 Month Contract** **Hybrid Work - 3 days/week from Mississauga 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...