Global Study Manager at AstraZeneca

Durham, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

21 Mar, 26

Salary

0.0

Posted On

21 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Project Management, Communication Skills, Relationship Building, Risk Management, Budget Tracking, Leadership Skills, Collaboration, Clinical Development, GCP Guidelines, Documentation, Vendor Management, Problem Solving, Process Improvement, Study Execution, Supply Chain Management

Industry

Pharmaceutical Manufacturing

Description

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. The role Drive end-to-end delivery of global clinical studies. As a Global Study Manager (GSM), you’ll coordinate cross-functional work from Protocol development through set-up, maintenance, close-out, CSR, and archiving—delivering to time, cost, and quality. You’ll partner with the GSD/GSAD and 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. What you’ll do 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. You will need to have: University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. 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. Knowledge of clinical development / drug development process in various phases of development and therapy areas Excellent knowledge of international guidelines ICH/GCP Excellent communication and relationship building skills, including external service provider management skills Good project management skills Demonstrated ability to collaborate as well as work independently, along with demonstrated leadership skills Are you interested in working at AZ, apply today! AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com. #LI-Hybrid Date Posted 20-Dec-2025 Closing Date 04-Jan-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

Responsibilities

Drive end-to-end delivery of global clinical studies, coordinating cross-functional work from protocol development through to archiving. Oversee day-to-day study execution, manage risks, and ensure inspection readiness.