The Global Study Associate Manager (GSAM) is a role within Development Operations and a member of the global study team. You will support the delivery of clinical studies from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR), and study archiving.

The GSAM works with internal and external partners to deliver delegated aspects of the clinical study. Responsibilities include assisting global study teams, leading administrative activities, overseeing systems for compliance tracking, and providing support for vendor oversight. Studies may span various therapeutic areas and all phases (I-IV), including Late Phase, Non-Interventional, Post-Authorization Safety Studies, Registries, Early Access Programs, etc.

You Will Be Responsible For:

• In collaboration with the global study team (GPD, GSAD, GSMs), other ARDU stakeholders, and key vendors, support activities for clinical study execution, ensuring adherence to timelines and quality standards.

• Taking a leading role in preparing study documents and documents related to key vendors, such as the Vendor Oversight Plan.

• Actively maintaining and facilitating interactions with cross-functional team members, including Data Management, Procurement, Regulatory, Patient Safety, and Quality Assurance.

• Collaborating closely with both internal and external partners to effectively execute delegated aspects of the clinical study, ensuring alignment with the objectives set by the GPD, GSAD, or GSM.

• Actively contributing to the planning and execution of both internal and external meetings.

• Taking a proactive role in identifying risks and issues and contributing to the development of mitigation and action plans.

• Providing support to the GSM in project and budget management, adhering to agreed-upon delegation.

• Actively participating in or taking a leadership role in departmental initiatives and/or Subject Matter Expert (SME) functions.

• Serving as a mentor and guide for team members, promoting their professional development and cultivating a collaborative work environment.

• Providing support for other study and functional activities as assigned.

You Will Need to Have:

• Bachelor’s degree or equivalent in a discipline related to clinical practice/healthcare, life sciences, or drug development, or commensurate work experience.

• Proficiency with technological systems (Microsoft Office, including Excel, PowerPoint, and SharePoint Online; eTMF and Veeva Systems).

• Excellent organizational, communication, and time management skills.

• High level of proactivity and willingness to take initiative.

• Strong relationship-building skills.

• Ability to work in an office environment, including using a computer, engaging in communications via phone, video, and electronic messaging, problem solving, analysis, dialogue, collaboration with others, and maintaining availability during standard business hours.

We Would Prefer for You to Have:

• More than 3 years of experience supporting global study teams in a clinical research environment.

• Ability to drive discussions around the scope of work and oversee vendor-related activities.

• Excellent knowledge of Essential Documents, CFR, and/or ICH-GCP.

• Demonstrated ability to collaborate effectively as well as work independently.

• Project management skills and basic PM methodology.

Alexion Canada

Since beginning our operations in Canada in 2009, Alexion has been working tirelessly to bring innovative medicines to the millions of Canadians living with rare diseases. Our pioneering 30-year legacy, our scientific expertise and our commitment to patient-centric decision-making are the foundations of what we are today – a company with a mission to transform lives.

Our Canadian team

We know that people living with a rare disease and their families deserve our unwavering commitment and investment into finding and accessing therapies that help them live longer, fuller lives. Our presence in Canada has grown to over 200 employees and includes a global research and development hub, made up of highly skilled professionals responsible for conducting our clinical trials in Canada and around the world, as well as our dedicated and passionate local teams that ensures our treatments reach those who need them. Together, we are driving patient impact locally and globally.

How we work
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Alexion embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Alexion is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.