08 sep
|
AstraZeneca
|
Laza
Are you ready to run integral 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
📌 Global Study Manager Early Oncology (Laza)
🏢 AstraZeneca
📍 Laza