Global Study Manager Early Oncology

Are you ready to run global oncology studies at pace and turn rigorous science into operational reality for patients sooner? In this role, you will orchestrate complex, multi-country trials from protocol through Clinical Study Report, ensuring quality and compliance while unblocking the path to decisive data.

Accountabilities

• Study Document Leadership: Drive the development, updates and amendments of core study documents, ensuring template and version compliance from start-up through closeout.
• Country Start-up and Submissions: Lead country-specific agreements, confidentiality agreements and clinical trial applications to enable rapid site activation across multiple geographies.
• Vendor Strategy and Oversight: Set up and manage third-party vendors, assess statements of work and budgets, oversee change orders, and ensure partners deliver to quality, timeline and cost.
• Data Delivery Enablement: Provide input to data management documents (e.g., CRF, data validation specifications) and partner with data management and sites to facilitate timely, high-quality data.
• Budget and Contracts Management: Initiate contract and budget requests, track status and deliverables, raise purchase orders, review invoices, and monitor spend against approved budgets.
• Supply and Materials Coordination: Secure investigational product and study materials by liaising with internal supply teams and external service providers to maintain uninterrupted trial conduct.
• Recruitment, Risk and Quality Oversight: Provide oversight of site and vendor performance, support recruitment and data delivery plans, and implement risk mitigation strategies to safeguard timelines and quality.
• Insurance and Regulatory Support: Assist with clinical trial insurance processes, tracking approvals, revisions and renewals to maintain coverage.
• Study Progress Monitoring: Monitor conduct and progress, proactively identifying and resolving issues that could impact quality, timelines or budget and escalating when needed.
• TMF Excellence and Inspection Readiness: Support set-up, maintenance, closeout and archiving of the Trial Master File, maintaining continual inspection readiness.
• Communications and Stakeholder Engagement: Prepare clear, concise materials for meetings, newsletters and internal portals to align stakeholders and sustain momentum.
• Audit and Inspection Preparation: Support the study team through audits and regulatory inspections, ensuring robust responses and sustained compliance.
• OP and Process Improvement: Contribute to reviews of new or updated SOPs and guidance documents, sharing learnings from studies to improve ways of working.

Skills / Experience

• University degree / Bachelor’s degree, preferably in medical or biological science, or discipline associated with Clinical Research, or equivalent experience. Minimum of 3-4 years of progressive clinical trial experience
• Experience of working with and delivering through strategic partners and 3rd party vendors - Excellent knowledge of ICH-GCP principles
• Team orientated
• Ability to coordinate and prioritise multiple tasks and deliverables
• Proactive approach
• High degree of flexibility
• Demonstrated verbal and written communication skills
• Good negotiation and collaboration skills
• Demonstrated interpersonal and problemsolving skills
• Some travel may be required

Desirable Skills / Experience

• Early phase oncology clinical trial experience
• Global study management experience

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 is. 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.