Global Study Manager, Oncology R&D, Early Oncology Clinical

Are you ready to lead complex, early-phase oncology studies that move bold science from hypothesis to patient impact? In this role, you will turn promising ideas into decision-ready data by aligning global teams, vendors, and sites around clear plans and standards. Your work will directly influence how fast we learn, pivot, and progress the next generation of cancer medicines. You will join a collaborative scientific community where industry-scale execution meets academic rigor. As the central driver of study delivery, you will optimize start-up, data flow, and inspection readiness across regions. Do you see yourself setting the pace for first-in-human and signal-finding trials, removing obstacles before they appear, and guiding a study from protocol to final report with confidence? Accountabilities: - Study Document Development: Contribute to the creation and maintenance of core study documents and amendments, ensuring template and version compliance to enable consistent, high-quality execution. - Country Activation: Lead the preparation of country-specific agreements, confidentiality agreements, clinical trial applications, and other local documents to secure timely approvals and site activation. - Vendor Strategy and Management: Set up third-party vendors, define initial statements of work and budgets, manage change orders, and maintain strong oversight to keep delivery on time and on budget. - Data Delivery Interface: Provide input to data management documents (including Case Report Forms and Data Validation Specifications), partner with data management and sites, and facilitate accurate, timely data flow for critical decisions. - Budget and Contracts: Initiate contract and budget requests, track status, support purchase order generation, review vendor invoices, and monitor spend against the approved budget to maintain financial control. - Supply and Logistics: Coordinate with Drug Supply and external service providers to ensure uninterrupted availability of investigational product and study materials at all sites. - Study Oversight and Quality: Monitor study conduct and progress, proactively resolve issues that threaten timelines, quality, or budget, and drive risk mitigation strategies that protect patient safety and data integrity. - Insurance and Compliance: Assist in the clinical trial insurance process; track approvals, revisions, and renewals; and support risk management and quality efforts to ensure compliance. - TMF and Inspection Readiness: Set up, maintain, close out, and archive the Trial Master File with continual inspection readiness, ensuring complete and audit-ready documentation throughout the study lifecycle. - Communications and Engagement: Prepare presentations and updates for meetings, newsletters, and websites to keep stakeholders aligned and informed. - Process Excellence: Contribute to the review of new or updated SOPs and guidance documents to strengthen consistency and continuous improvement across studies. Essential Skills/Experience: - Contribute to the development of study documents as appropriate as well as any updates/amendments, ensuring template and version compliance. - Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and other applicable country documents. - Manage the set-up of third-party vendors assessing initial statement of work and budget, as well as the change order process. - Provide input to data management documents (e.g. Case Report Form, Data Validation Specifications), and interface with data management representatives and sites to facilitate the delivery of study data. - Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and assist in tracking spend against approved budget. - Ensure the supply of Investigational product and study materials by liaising with Drug Supply or external service providers as appropriate. - Oversight of third party vendors, global / local internal staff and investigator sites to support effective delivery of a study and its regulatory documents from development of the protocol through to the Clinical Study Report. - Provide oversight of and support recruitment and data delivery as well as risk mitigation strategies. - Assist in the clinical trial insurance process; track approvals, revisions and renewals of certificates. - Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timelines or budget. - Support risk management and quality efforts to ensure study compliance. - Support set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual inspection readiness. - Prepare presentation material for meetings, newsletters and websites. - Support the study team in the implementation of audits and regulatory inspections. - Contribute to review of new/amended/unique SOPs and guidance documents. Desirable Skills/Experience: - Experience leading global, multi-center early-phase (Phase I/II) oncology studies. - Strong knowledge of ICH-GCP, clinical operations processes, and inspection readiness best practices. - Proven vendor governance across biometrics, central labs, ePRO/IRT, imaging, and other specialized providers. - Proficiency with EDC, eTMF, and risk-based quality management tools. - Demonstrated ability to manage complex budgets and contract workflows across multiple regions. - Excellent cross-functional communication, influencing skills, and stakeholder management at global scale. - Degree in life sciences or related field, or equivalent clinical research experience. 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. Why AstraZeneca: Here, your leadership turns discovery into outcomes that matter for people with cancer. You will work side by side with scientists, clinicians, technologists, and operations experts who blend academic insight with industrial scale, supported by modern platforms and a pipeline designed to learn fast and advance the most promising ideas. Expect real collaboration across borders, a leadership community that reflects many perspectives, and access to partnerships with world-class cancer centers that accelerate complex research. We value kindness alongside ambition, encourage smart risk-taking, and back you with the tools and peers to shape studies that change clinical practice. Call to Action: Lead the studies that set new standards in early oncology and amplify your impact—take your next step with us today. Date Posted 14-ene-2026 Closing Date 27-ene-2026 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.