AstraZeneca

Healthcare

GlobalStudyManagerEarlyOncology

€55–75k ~AI est. Cuenca, Spain; Albacete, Spain FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“Global Study Manager Early Oncology at AstraZeneca. Skills: Oncology studies, Clinical trial operations, Vendor oversight. Drive core document development. Update core documents”

What You'll Achieve.

Deliver clean data faster; Raise bar on inspection readiness; Accelerate outcomes

Industry & Context.

Healthcare
Problems you'll solve

Problem-solving

Eligibility Requirements

Some travel

What They're Looking For.

Must Have

University degree or equivalent experience, 3-4 years clinical trial experience, ICH-GCP principles knowledge

Nice to Have

Early phase oncology experience, Global study management experience

What You'll Do.

Drive core document development

Update core documents

Lead country start-up

Enable rapid site activation

Assess statements of work

Oversee change orders

Ensure partner quality

Ensure partner timelines

Provide input to data management documents

Facilitate timely data

Facilitate high-quality data

Initiate contract requests

Initiate budget requests

Raise purchase orders

Monitor spend against budgets

Secure investigational product

Secure study materials

Maintain uninterrupted trial conduct

Oversee site performance

Oversee vendor performance

Support recruitment plans

Support data delivery plans

Implement risk mitigation strategies

Assist with insurance processes

Track insurance approvals

Track insurance revisions

Track insurance renewals

Monitor study conduct

Monitor study progress

Support TMF maintenance

Support TMF archiving

Maintain inspection readiness

Prepare meeting materials

Prepare newsletter materials

Prepare internal portal materials

Support audit preparation

Support inspection preparation

Ensure robust responses

Ensure sustained compliance

Contribute to SOP reviews

Contribute to guidance document reviews

Share study learnings

Improve ways of working

How You'll Work.

Team & Collaboration

Empowered team; Cross-functional teams; Internal supply teams; External service providers; Stakeholder engagement

Communication Scope

Verbal communication; Written communication

Process & Methodology

Study document leadership, Country start-up, Vendor strategy, Data delivery, Budget management, Contract management, Supply coordination, Risk oversight, Quality oversight, TMF excellence, Inspection readiness, Audit preparation, Process improvement

Full Job Description

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 oversi

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