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, Relationship Building, Risk Management, Budget Tracking, Documentation, Collaboration, Leadership, Problem Solving, Vendor Management, Inspection Readiness, Clinical Supply Chain, Process Improvement, GCP Compliance, Study Execution

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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Responsibilities

Drive end-to-end delivery of global clinical studies, overseeing day-to-day execution and coordinating cross-functional work. Manage relationships with CROs and ensure compliance with regulatory standards.