Global Study Manager

Introduction to role:

As a Global Study Manager (GSM) at AstraZeneca, you will be an integral part of the extended global study team, supporting the delivery of clinical studies in Haematology Clinical Operations. From the development of the Clinical Study Protocol (CSP) through to study set-up, maintenance, close-out, and archiving, you will ensure that studies are delivered on time, within budget, and to the highest quality standards. You will provide country and vendor oversight, working cross-functionally with internal and external partners to execute clinical studies in accordance with the Global Study Director (GSD) or Global Study Associate Director (GSAD), adhering to AstraZeneca's values and behaviors.

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 the set-up of third-party vendors, including initial statement of work, budget assessment, and change order processes.
• Provide oversight to ensure study delivery in partnership with AZ enablement team, clinical experts, and external service providers.
• Maintain interactions with internal functions (Enablement, Data Management, Procurement, Regulatory, Patient Safety, Quality Assurance) and external functions (CROs, other service providers) to ensure efficient study delivery.
• Contribute to the planning and conduct of internal and external meetings.
• Ensure the supply of investigational products and study materials by liaising with Global Clinical Supply or external service providers.
• Support risk management and quality efforts to ensure study compliance.
• Ensure all study documents within GSM’s scope are complete and verified for quality in the Trial Master File.
• Support GSD/GSAD with budget management, including external service provider invoice reconciliation.
• Adhere to global clinical processes, procedural documents, applicable Quality & Compliance manual documents, and international guidelines such as ICH/GCP.
• Support GSADs in project management as per agreed delegation.
• For outsourced studies, support GSD/GSAD in managing the CRO Project Manager to ensure study delivery according to timelines, budget, and quality standards.
• Support the study team in implementing audits and regulatory inspections.
• Contribute to reviewing new/amended/unique SOPs and guidance documents throughout the study lifecycle.
• Take on assignments in process improvements or leading improvement projects as agreed with the manager.

Essential Skills/Experience:

• University level bachelor’s degree (or equivalent), preferably in medical or biological sciences or discipline 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 timelines, 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.
• Ability to manage competing priorities.

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

At AstraZeneca, we are at the forefront of science, taking an inter-disciplinary approach that includes novel biomarkers, AI, novel endpoints, and cutting-edge trial designs. Our commitment to innovation allows us to develop life-changing medicines that transform cancer treatment and improve patient outcomes globally. We are united in our vision to eliminate cancer as a cause of death by pushing the boundaries of science.

Join us in making a meaningful difference—apply today!

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.