Global Study Manager

Role Summary

Drive end-to-end delivery of global clinical studies as a Global Study Manager (GSM). Coordinate cross-functional work from protocol development through setup, maintenance, close-out, CSR, and archiving—delivering to time, cost, and quality. Partner with internal/external teams to execute delegated study activities in line with the Delivery Model, AZ Project Management Framework, ICH-GCP, AZ SOPs, policies, and values.

Responsibilities

• Lead coordinated delivery: Oversee day-to-day study execution with AZ experts and external providers to meet timelines, budget, and quality targets.
• Shape study documentation: Draft/own delegated documents (e.g., ICFs, master Clinical Study Agreements) and vendor materials (specs, procedures, presentations).
• Orchestrate partners: Maintain productive relationships with CROs and other providers; plan and run key meetings (e.g., Investigator/Monitor meetings).
• Secure supplies: Liaise with Clinical Supply Chain and vendors to ensure uninterrupted IP and study material supply.
• Manage risk and issues: Proactively identify, mitigate, and track risks/actions; escalate with context and solutions.
• Ensure inspection readiness: Keep Trial Master File content complete, accurate, and quality-verified; adhere to processes and ICH-GCP at all times.
• Support financials: Assist with budget tracking and invoice reconciliation; contribute to transparent cost management.
• Govern outsourced delivery: Support oversight of CRO Project Managers and document oversight per AZ SOPs (e.g., services/TOO).
• Improve how we work: Lead or contribute to non-drug improvement projects to streamline processes and outcomes.

Qualifications

• Required: University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
• Required: 2+ years experience in all phases of a clinical study lifecycle with relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years.
• Required: Knowledge of clinical development / drug development process in various phases of development and therapy areas
• Required: Excellent knowledge of international guidelines ICH/GCP
• Required: Excellent communication and relationship building skills, including external service provider management skills
• Required: Good project management skills
• Required: Demonstrated ability to collaborate as well as work independently, along with demonstrated leadership skills