Global Study Manager

Introduction to role:

Are you ready to make a difference in the world of clinical studies? As a Global Study Manager, you'll be at the heart of delivering life-changing medicines through Cell Therapy Clinical Operations. You'll play a pivotal role in ensuring clinical studies are executed to time, cost, and quality standards. From developing Clinical Study Protocols to overseeing country and vendor operations, you'll collaborate with internal and external partners to bring innovative treatments to patients. Are you prepared to push the boundaries of science and transform lives?

This is a global role with the opportunity to be based in other locations where there is a Global Hub or Strategic Site.  

Accountabilities:

• Contribute to the development and updates of study documents, ensuring compliance with templates and versions.

• Lead or contribute to the preparation of study documents and external service provider-related documents.

• Manage third-party vendor setup, including initial statement of work, budget assessment, and change order processes.

• Provide oversight in partnership with AZ enablement teams and external service providers to ensure study delivery.

• Facilitate interactions with internal functions and external service providers for efficient study delivery.

• Plan and conduct internal and external meetings, such as Investigators/Monitors meetings.

• Ensure supply of investigational products and study materials through coordination with Global Clinical Supply or external providers.

• Support risk management and quality efforts for study compliance.

• Verify quality of study documents within GSM's scope for Trial Master File completeness.

• Assist GSD/GSAD with budget management, including external service provider invoice reconciliation.

• Adhere to global clinical processes, procedural documents, and international guidelines for inspection readiness.

• Support GS(A)Ds in project management as per agreed delegation.

• For outsourced studies, assist GSD/GSAD in managing CRO Project Manager for timely, budget-conscious, quality study delivery.

• Support study team in audits and regulatory inspections implementation.

• Review new/amended SOPs and guidance documents throughout study lifecycle.

• Undertake assignments on non-drug project work in process improvements or leading improvement projects.

Essential Skills/Experience:

• University level bachelor's degree (or equivalent), preferably in medical or biological sciences or disciplines associated with clinical research.

• Minimum of 5 years progressive experience in clinical research, with at least 3 years of clinical development project management experience or equivalent.

• Extensive knowledge of clinical research regulatory requirements (incl ICH-GCP) and demonstrated abilities in clinical study management processes and clinical/drug development.

• Extensive and proven experience in driving operational delivery to timeline costs, and quality.

• Proven experience leading delivery through internal and external organizations.

• Strong, demonstrated abilities/skills in matrix team leadership.

• Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills.

• Experience in providing clear requirements and selection of external contracts.

• Excellent communication and interpersonal skills.

• Strong strategic and critical thinking abilities.

• Strong organizational and problem-solving skills.

Desirable Skills/Experience:

• Higher university degree e.g. PhD, MSc.

• Experience in all phases of a clinical study lifecycle.

• Basic knowledge of GXP outside of GCP (i.e., GMP/GLP).

• Experience in hematology therapeutic area.

• Vendor management experience (e.g., IRT, labs, etc.).

WHY JOIN US?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.

SO, WHAT’S NEXT?

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

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.

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
• Learn more about working with us in Canada
• View our YouTube channel

Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca 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.

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Date Posted

Closing Date

AstraZeneca 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.