Astrazeneca

Cell Therapy

GlobalStudyManager

Gaithersburg, Maryland, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid candidates.

The Brief

“Global Study Manager at Astrazeneca. Skills: Clinical study delivery, Cross-functional collaboration, Study document preparation, Study conduct monitoring. Deliver clinical studies to time, cost and quality. Build partnerships with internal and external partners”

What You'll Achieve.

Successful study delivery; Efficient study delivery; Study delivery to quality; Study delivery to timeline; Study delivery to budget objectives

Industry & Context.

Cell Therapy
Problems you'll solve

Analytical skills; Identifying and resolving risks; Identifying and resolving issues

What They're Looking For.

Must Have

Bachelor's degree, Minimum 5 years' experience within the pharmaceutical industry supporting clinical operations, Project management skills, Organizational skills, Analytical skills, Knowledge of clinical development / drug development process, Knowledge of international guidelines ICG-GCP

Nice to Have

Previous Cell Therapy experience

What You'll Do.

Deliver clinical studies to time

Build partnerships with internal and external partners

Provide oversight for study delivery

Facilitate interactions with internal functions

Facilitate interactions with external functions

Lead preparation of delegated study documents

Participate in preparation of delegated study documents

Support GSAD in project management

Ensure supply of study materials

Ensure supply of Investigational product

Support GSAD with budget management

Ensure studies are inspection-ready

Complete and verify study documents

Assist with planning internal meetings

Assist with planning external meetings

Monitor study conduct and progress

Identify and resolve study risks

Identify and resolve study issues

Provide direction to team

Facilitate positive team dynamics

Collect Adverse Events

Report Adverse Events

How You'll Work.

Team & Collaboration

Work cross-functionally building partnerships; Collaborative culture; Knowledge-sharing; Work across teams, functions and globe

Process & Methodology

Project management, Organizational skills, Analytical skills, Support GSAD in project management, Budget management

Full Job Description

**WE ARE BUILDING PIPELINE OF CANDIDATES - THIS IS NOT ACTIVE RECRUITMENT** In AstraZeneca's Cell Therapy division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. We have the potential to grow our pipeline and positively impact the lives of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. This role is part of the Oncology R&D team tasked with supporting Clinical and Commercial production across multiple sites. 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. As the Global Study Manager, you are a member of the extended global study team supporting the Cell Therapy department for delivery of clinical studies to time, cost and quality from Clinical Study Protocol (CSP) development through to study archiving. You will report to the Clinical Program Director and will be based in Gaithersburg, MD. **You will:** * ​Work cross-functionally building partnerships with internal and external partners to deliver and provide oversight to ensure successful study delivery. * Maintain and facilitate interactions with internal functions including Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other outside service providers to ensure an efficient study delivery. * Lead and/or participate in the preparation of delegated study documents (e.g. Informed Consent Form, master Clinical Study Agreement etc.) and external service provider related documents (e.g. specifications) * Support the Global Study Associate

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