Global Study Manager
About The Position
The Global Study Manager (GSM) is a member of the extended global study team supporting the delivery of clinical studies within BioPharmaceuticals Clinical Operations. The GSM is responsible for supporting study management activities to ensure delivery to agreed timelines, budget, and quality standards, from Clinical Study Protocol (CSP) development through study start-up, maintenance, close-out, Clinical Study Report (CSR) development, and study archiving. The GSM partners cross-functionally with internal and external stakeholders to execute delegated aspects of clinical studies in accordance with the direction of the Global Study Director (GSD) or Global Study Associate Director (GSAD). The role ensures compliance with AstraZeneca's Delivery Model, Project Management Framework, applicable regulations including ICH GCP, company SOPs, policies, guidelines, values, and behaviors.
Requirements
- Bachelor's degree in medical, Biological, Life Sciences, or a related clinical research discipline.
- Minimum of 3 years of relevant experience within the pharmaceutical industry, contract research organization, biotechnology company, or academic clinical research environment.
- Knowledge of clinical development and drug development processes across multiple phases and therapeutic areas.
- Strong understanding of ICH-GCP and global clinical trial regulations.
- Excellent communication, collaboration, and stakeholder management skills.
- Experience managing external service providers and/or CROs.
- Demonstrated project management skills.
- Ability to work effectively both independently and within cross-functional teams.
- Demonstrated leadership and problem-solving capabilities.
- Strong computer proficiency and experience using clinical systems and business applications.
- Excellent written and verbal communication skills in English.
Nice To Haves
- Advanced degree (Master's, PharmD, PhD, or equivalent).
- Experience across the full clinical study lifecycle from start-up through close-out.
- Knowledge of additional GxP areas, including GMP and GLP.
- Experience supporting global clinical studies and outsourced delivery models.
Responsibilities
- Partner with internal clinical teams, subject matter experts, CROs, and external service providers to ensure successful study delivery.
- Lead and contribute to preparation of study documents, including informed consent forms, master clinical study agreements, study-specific procedures, specifications, presentations, and other required documents.
- Coordinate and facilitate interactions between internal functions, CROs, and external vendors to support efficient study execution within timeline, budget, and quality expectations.
- Support the planning and execution of internal and external meetings, including investigator and monitor meetings.
- Ensure investigational product and study material supply through collaboration with Clinical Supply Chain and external partners.
- Identify study risks and issues proactively and contribute to mitigation and action plans.
- Ensure study-related documentation within assigned scope is complete, accurate, and maintained in the Trial Master File (TMF).
- Support budget management activities, including invoice reconciliation and vendor financial tracking.
- Adhere to global clinical processes, Quality & Compliance requirements, and international regulations to ensure inspection readiness at all times.
- Provide project management support to the GSD and/or GSAD as delegated.
- Support management and oversight of CRO Project Managers for outsourced studies, ensuring delivery against agreed timelines, budgets, and quality standards while maintaining appropriate documented oversight.
- Participate in process improvement initiatives and lead non-drug project work as assigned.
Benefits
- Competitive base salary, annual bonus, and long-term incentives
- Generous paid time off program
- Comprehensive benefits package
- Qualified retirement program [401(k) plan]
- Paid vacation and holidays
- Paid leaves
- Health benefits including medical, prescription drug, dental, and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
