Global Study Manager Early Oncology

Astrazeneca Plc; Laza; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

AstraZeneca is seeking an experienced Clinical Trial Manager to orchestrate multi-country oncology studies from protocol through CSR. You will lead country-startup, vendor oversight, and data delivery while ensuring quality, compliance, and timely data for decision-making.

Join a fast-moving team of study operations, data management, patient safety, supply chain, and regulatory experts to accelerate outcomes and maintain inspection readiness.

Formación

• University degree in medical or biological science or equivalent.
• Minimum 3–4 years of progressive clinical trial experience.
• Experience with strategic partners and 3rd party vendors; strong ICH-GCP knowledge.

Responsabilidades

• Lead country start-up activities and submissions to enable rapid site activation across geographies.
• Drive study document leadership from start-up to closeout with template and version control.
• Oversee vendor strategy, budgets, SOs, change orders and invoices to ensure quality and timeliness.
• Support data delivery by guiding CRF design and data validation specs with sites and data management.
• Monitor study progress, risk management and escalation to safeguard timelines and budget.
• Maintain Trial Master File setup, maintenance, and inspection readiness.

Conocimientos

Vendor management

ICH-GCP knowledge

Cross-functional collaboration

Coordination & prioritization

Communication skills

Travel readiness

Educación

Bachelor’s degree in medical/biological sciences

Descripción del empleo

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.

You will join a fast-moving, empowered team that brings together study operations, data management, patient safety, supply chain, and regulatory experts to deliver high-quality studies across multiple countries. Expect to make clear decisions, challenge constructively, and take smart, evidence-based risks to accelerate outcomes. How will you use your vendor leadership and ICH-GCP expertise to deliver clean data faster and raise the bar on inspection readiness?

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. Essential

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

Why AstraZeneca

Here, bold science meets decisive execution. We pursue life-changing oncology outcomes and invest deeply in the studies that can get us there, bringing diverse experts together—often in the same room—to move faster on the evidence. When the world needed speed, our teams mobilized, designed and launched a clinical trial in weeks, proving how scale and agility can accelerate discovery without compromising rigor. You will work with high-quality molecules across multiple indications, use modern tools and data to push the frontier of what’s possible, and be supported to make clear decisions that keep patients at the center. We value kindness alongside ambition, and we back people who speak up, collaborate across boundaries, and turn thoughtful risk into progress.

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.