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Introduction to role: Are you ready to bring discipline, creativity, and momentum to global clinical studies that advance medicines for patients who need them most? Do you see yourself orchestrating diverse teams and suppliers to deliver high-quality trials on time and on budget?
As a Global Study Manager, you will provide end-to-end oversight of assigned studies, partnering closely with internal experts and external service providers to turn robust plans into reliable execution. You will be central to how we deliver, using clear governance, smart risk management, and crisp communication to keep studies inspection ready and moving with pace.
You will join a driven, collaborative team that embraces experimentation and data-enabled decision-making. Here, your judgment and leadership will shape study operations from documents and meetings to CRO performance and supply continuity—ultimately accelerating therapies that make a real difference for patients.
Accountabilities: Study Delivery Oversight: Own day-to-day oversight with internal teams, clinical experts, and external providers to deliver studies to agreed timelines, budget, and quality—linking operational decisions to patient impact and portfolio value.
Document Leadership: Lead and contribute to the preparation of key documents, including Informed Consent Forms, master Clinical Study Agreements, vendor specifications, study procedures, and presentations—ensuring clarity, compliance, and reuse across programs.
Vendor and CRO Partnership: Maintain strong, structured interactions with CROs and vendors; for outsourced studies, support management of the CRO Project Manager to drive performance, while documenting oversight in line with SOPs and transfer-of-obligations requirements.
Meeting Planning and Execution: Plan and conduct internal and external meetings, such as Investigators’ and Monitors’ meetings, to align stakeholders, compress decision cycles, and expedite study milestones.
Supply Coordination: Liaise with Clinical Supply Chain and external providers to ensure uninterrupted supply of investigational product and study materials, anticipating needs and solving bottlenecks before they affect sites or patients.
Risk and Issue Management: Proactively identify risks and issues; develop mitigation and action plans that protect data integrity, patient safety, and delivery commitments—keeping studies inspection-ready at all times.
TMF Quality Stewardship: Ensure that all study documents within scope are complete and quality-verified in the Trial Master File, enabling traceability and audit readiness.
Budget and Vendor Finance Support: Support GSD and/or GSAD with budget management, including external service provider invoice reconciliation, linking spend to milestones and value.
Project Management Support: Support overall project management as delegated, bringing cadence, transparency, and problem-solving to cross-functional teams.
Process Improvement: Take on non-drug project work to improve processes and lead improvement initiatives—translating lessons learned into scalable practices that accelerate future studies.
Compliance and Standards: Adhere to global clinical processes, procedural documents, Quality & Compliance manual documents, and ICH/GCP, ensuring consistent, inspection-ready execution across the study lifecycle.
Essential Skills/Experience:
University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Experience providing oversight to ensure study delivery in partnership with internal teams, clinical experts, and external service providers. Demonstrated ability to lead and contribute to the preparation of study documents, including Informed Consent Forms, master Clinical Study Agreements, vendor specifications, study-specific procedures, descriptions, and presentations. Experience maintaining and facilitating interactions with CROs and other external service providers to deliver to time, cost, and quality objectives. Experience planning and conducting internal and external meetings, such as Investigators’ and Monitors’ meetings. Experience liaising with Clinical Supply Chain or external providers to ensure supply of investigational product and study materials. Proven ability to proactively identify risks and issues and to develop mitigation and/or action plans. Experience ensuring that study documents within scope are complete and verified for quality in the Trial Master File. Experience supporting GSD and/or GSAD with budget management, including external service provider invoice reconciliation. Consistent adherence to global clinical processes, procedural documents, applicable Quality & Compliance manual documents, and ICH/GCP to maintain inspection readiness. Experience supporting GSD and/or GSAD with overall project management as delegated. For outsourced studies, experience supporting management of the CRO Project Manager to ensure delivery according to agreed timelines, budget, and quality standards, while maintaining and documenting appropriate oversight throughout the study lifecycle, in accordance with relevant SOPs and guidelines (e.g., description of services and transfer of obligations). Experience taking on assignments in process improvements and/or leading improvement projects.
Desirable Skills/Experience: Experience delivering global, multicenter studies across multiple phases or therapeutic areas. Expertise with eTMF systems, study start-up workflows, and site activation optimization. Strong vendor governance capabilities, including performance metrics, risk-based oversight, and contract change control. Exposure to inspection/audit preparation and response, with a record of successful outcomes. Proficiency with budget tracking tools and financial reconciliation for outsourced activities. Formal project management training or certification (e.g., PMP) and/or Lean or Six Sigma experience. Ability to translate complex operational issues into clear, actionable plans for cross-functional teams. Strong communication skills that build trust across geographies and cultures, with a focus on decision-speed and clarity.
Annual base salary for this position ranges from $109,148.80 to $143,257.80. AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances.
In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.
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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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⠀ Annual base salary for this position ranges from 109,148.80 to 143,257.80.AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances.
In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.
We are using AI as part of the recruitment process.
This advertisement relates to a current vacancy.