Global Study Associate

5 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 medicines that transform lives. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you’re swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

**Accountabilities/Responsibilities**:

- Contribute to clinical study start-up, execution, close-out and reporting
- Collect, review and track regulatory and other relevant documents. Interface with Investigators, Strategic Partners, Site Management & Monitoring and internal staff during the collection process to support effective delivery of a study and its regulatory documents through finalization of the Clinical Study Report (CSR)
- Initiate and lead the set-up of the electronic Trial Master File (eTMF) including tracking of documents. Maintain and close the eTMF ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance
- Initiate and maintain production of study documents, ensuring template and version compliance
- Create and/or import clinical-regulatory documents into the Global Electronic Library (GEL) according to the Global Document List (GDL) and maintain documents according to current process ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents to support publishing in GEL
- Plan and proactively collate the administrative appendices for the CSR
- Interface with Data Management Centre and/or Data Management Enablement representatives to facilitate the delivery of study related documents
- Coordinate administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs
- Prepare, contribute to and distribute presentation material for meetings, newsletters and web-sites

**Minimum Requirements**

Education and Experience
- ** Relevant experience from within the pharmaceutical industry or similar organization, preferably of at least 1 years** - knowledge of clinical development / drug development process in various phases of development and therapy areas;
- Level of education that supports Skills and Capabilities of the position and ensures successful conduct of accountabilities/responsibilities and appropriate interactions with internal/external customers
- Proven organizational and analytical skills
- Previous administrative training/experience
- Computer proficiency
- Excellent knowledge of spoken and written English
- Project management experience - desirable

Skills and Capabilities
- Develop working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines
- Ability to develop advanced computer skills to increase efficiency in day-to-day tasks
- Excellent verbal and written communication and presentation skills
- Demonstrate ability to work independently, as well as in a team environment
- Ability to prioritise and manage multiple tasks with conflicting deadlines
- Good interpersonal skills and ability to work in a team environment


  • Global Study Associate

    6 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...


  • 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 weeks 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...


  • 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

    5 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

    5 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...


  • 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 Director

    4 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....


  • 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...


  • 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...


  • 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 multiple...

  • Global Study Manager

    5 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

    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...


  • 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...


  • 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...


  • 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...


  • 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...


  • 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...


  • Mississauga, Canada AstraZeneca Full time

    **This opportunity is available at our Gaithersburg, MD, Waltham, MA (USA); Mississauga (CAN); or Barcelona (ESP) location.** Within Hematology R&D, we are committed to advancing the science to deliver life-changing medicines to patients most in need. With a combination-focused pipeline that exploits the power of six scientific platforms (Immuno-Oncology,...


  • Mississauga, Canada AstraZeneca Full time

    **Study Delivery Associate (12 Month Contract)** **Hybrid Work - 3 days/week at our Mississauga, ON 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...