Global Study Manager

The Global Study Manager plays a central role in delivering clinical studies to time, cost and quality, from Clinical Study Protocol development through study set-up, maintenance, close-out, Clinical Study Report development and study archiving. Working cross-functionally with internal and external partners, the Global Study Manager supports the Global Study Director or Global Study Associate Director in delegated aspects of clinical study execution, ensuring alignment with the Delivery Model, AstraZeneca Project Management Framework, ICH GCP, AstraZeneca Standard Operating Procedures, policies, guidelines and values. Ready to help turn complex science into well-run, inspection-ready studies that make a real difference to patients?

Accountabilities:

The Global Study Manager partners with AstraZeneca teams, clinical experts and external service providers to provide oversight and ensure robust study delivery. This includes leading or contributing to the preparation of delegated study documents such as Informed Consent Forms, master Clinical Study Agreements and external service provider documentation including specifications, study-specific procedures, descriptions and presentations. The role maintains and facilitates effective interactions with internal functions, CROs and other external service providers to secure efficient delivery against time, cost and quality objectives. The Global Study Manager contributes to the planning and conduct of internal and external meetings, such as Investigators’ and Monitors’ meetings, and ensures the supply of investigational product and study materials by liaising with Clinical Supply Chain or external partners. A key part of the role is proactive risk and issue identification, developing mitigation and action plans, and ensuring that all study documents within scope are complete and quality-verified in the Trial Master File. The Global Study Manager supports budget management activities including external service provider invoice reconciliation, adheres to global clinical processes and quality requirements to keep studies inspection ready at all times, and supports overall project management as delegated. For outsourced studies, the role supports management of the CRO Project Manager to ensure delivery to agreed timelines, budget and quality standards, while maintaining and documenting appropriate oversight throughout the study lifecycle. In addition, the Global Study Manager may take on non-drug project assignments focused on process improvements or leading improvement projects agreed with their manager. Interested in combining operational excellence with continuous improvement to advance clinical development?

Essential Skills/Experience:

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.

• Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years.

• Knowledge of clinical development / drug development process in various phases of development and therapy areas

• Excellent knowledge of international guidelines ICH/GCP

• Excellent communication and relationship building skills, including external service provider management skills

• Good project management skills

• Demonstrated ability to collaborate as well as work independently

• Demonstrated leadership skills

• Computer proficiency, advanced computer skills in day-to-day tasks

• Excellent verbal and written communication in English

Desirable Skills/Experience

• Advanced degree

• Experience in all phases of a clinical study lifecycle

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

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 we need 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.

At AstraZeneca, science sits at the heart of every decision, from early discovery through late-stage development and beyond. Here, curious minds collaborate across disciplines to explore new ways of treating, preventing and modifying complex diseases, using data, technology and deep biological insight to unlock the next wave of breakthroughs. Teams work closely with academia, biotechs and industry partners, sharing knowledge openly so that learning never stops and ideas move quickly into action. It is an environment that encourages bold questions, embraces uncertainty and sees both successes and setbacks as vital steps towards better therapies for patients worldwide.

If you are ready to use your expertise in clinical study management to help deliver life-changing medicines, apply now and join us on this journey!

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.