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

Are you ready to accelerate early oncology studies that could change the trajectory of cancer care? As a Global Study Manager, you will turn complex protocols into operational reality, enabling decisive progress in first-in-human and proof-of-concept trials that put patients first.

You will join a team that values speed and scientific rigor, empowered by leadership to make evidence-based decisions and move at pace. When urgent opportunities arise, we mobilize quickly—turning ideas into well-designed trials and actionable data in weeks, not months. Your work will ensure study start-up, recruitment, data delivery and inspection readiness happen without delays.

Do you thrive at the intersection of operations, data quality and vendor management? In this role, your judgment and ownership will directly influence timelines, budget control and regulatory success across a global network of sites.

Accountabilities:

• Study Document Development and Compliance: Contribute to study documents and manage updates/amendments, ensuring templates and version control are followed to maintain clarity and auditability.

• Country Start-up Leadership: Lead preparation of country-specific agreements, confidentiality agreements, clinical trial applications and other local documents to enable timely, compliant activation.

• Vendor Set-up and Management: Set up and manage third-party vendors, assess statements of work and budgets, and own the change order process to keep delivery aligned to scope, quality and value.

• Data Delivery Enablement: Provide input to data management documents such as Case Report Forms and Data Validation Specifications, and partner with data management teams and sites to secure high-quality, on-time data.

• Financial Stewardship: Initiate contract and budget requests, track status, generate purchase orders, review invoices and track spend against approved budgets to ensure financial control.

• Investigational Product and Materials Supply: Liaise with Drug Supply and external providers to secure uninterrupted provision of investigational product and study materials.

• Operational Oversight Across the Lifecycle: Oversee third-party vendors, global and local internal staff and investigator sites from protocol development through the Clinical Study Report to deliver to plan.

• Recruitment and Risk Mitigation: Provide oversight and support for patient recruitment and data delivery, proactively implementing risk mitigation strategies to protect timelines and quality.

• Insurance Management: Assist in the clinical trial insurance process and track approvals, revisions and renewals of certificates for continuous coverage.

• Study Monitoring and Issue Resolution: Monitor study conduct and progress, identifying and resolving issues that may impact quality, timelines or budget to keep studies on track.

• Risk Management and Quality: Support risk management and quality efforts to ensure regulatory and SOP compliance.

• TMF Excellence: Support set-up, maintenance, closeout and archiving of the Trial Master File, ensuring continual inspection readiness.

• Communication and Engagement: Prepare presentation materials for meetings, newsletters and websites to inform, align and motivate stakeholders.

• Audit and Inspection Readiness: Support the study team in the implementation of audits and regulatory inspections to secure successful outcomes.

• Continuous Improvement: Contribute to review of new, amended or unique SOPs and guidance documents to drive operational excellence.

Essential Skills/Experience:

• Proven experience contributing to study document development and amendments with strict template and version compliance.

• Experience leading preparation of country-specific agreements, confidentiality agreements, clinical trial applications and other local documents.

• Demonstrated ability to set up and manage third-party vendors, including statements of work, budgets and change orders.

• Experience providing input to data management documents such as Case Report Forms and Data Validation Specifications, and partnering with data management and sites to facilitate data delivery.

• Capability to initiate contract and budget requests, track status, generate purchase orders, review vendor invoices and track spend against approved budgets.

• Experience coordinating investigational product and study materials supply with Drug Supply teams or external providers.

• Experience overseeing third-party vendors, global and local internal staff and investigator sites from protocol development through Clinical Study Report.

• Experience supporting recruitment and data delivery and implementing risk mitigation strategies.

• Experience assisting with clinical trial insurance processes and tracking approvals, revisions and renewals of certificates.

• Experience monitoring study conduct and progress and proactively resolving issues impacting quality, timelines or budget.

• Experience supporting risk management and quality efforts to ensure study compliance.

• Experience setting up, maintaining, closing and archiving the Trial Master File with continuous inspection readiness.

• Experience preparing presentation materials for meetings, newsletters and websites.

• Experience supporting audits and regulatory inspections.

• Experience contributing to review of new, amended or unique SOPs and guidance documents.

Desirable Skills/Experience:

• Background in early-phase oncology trials across multiple countries.

• Familiarity with ICH-GCP, global regulatory requirements and ethics submissions.

• Proficiency with clinical systems such as EDC, CTMS, eTMF and vendor portals.

• Strength in budget management, contract negotiation and change control.

• Ability to lead cross-functional teams and influence without authority in a fast-paced environment.

• Strong analytical skills to anticipate operational risks and drive mitigation.

• Clear, concise communication and stakeholder engagement skills, including creation of executive-ready materials.

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, ambition meets kindness in a community united by a clear purpose: transform outcomes for people living with cancer. You will work with scientists, clinicians, technologists and operations experts who bring together cutting-edge science and modern tools to break through complexity and move faster for patients. Backed by meaningful investment and a rich pipeline across multiple indications, we mobilize quickly when the world needs answers—bringing the right minds together to turn evidence into action. Your contribution will shape how innovative medicines reach patients sooner, while you grow through stretch opportunities, trusted ownership and collaborative problem-solving.

Call to Action:
If you are ready to lead global studies with pace, precision and impact, step into this role and help shape the next wave of oncology breakthroughs.

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.