Global Study Associate
About The Position
The Global Study Associate (GSA) supports the delivery of global clinical studies from set-up through maintenance, close-out, and archiving. The role supports the Global Study Director, Global Study Associate Director, and/or Global Study Manager by coordinating activities and helping ensure quality and consistency. It also provides administrative and systems support and undertakes other delegated aspects of clinical study execution in accordance with applicable clinical trial regulations, including ICH-GCP, AstraZeneca SOPs, policies, best practices, and values and behaviours. The GSA may support multiple studies and delivery models concurrently. The role includes study documentation and systems administration, support for regulatory submissions and transparency activities, coordination of vendors and stakeholders, and logistical support for study operations, meetings, audits, and inspections. The GSA may also contribute to non-drug process-improvement projects as agreed with their manager.
Requirements
- Bachelor-level education in any discipline.
- At least 2 years of proven study administration/assistant or relevant study-level experience, including experience with the clinical study lifecycle.
- Proven organizational and analytical skills.
- Previous administrative training or experience.
- Computer proficiency for day-to-day tasks.
- Ability to develop working knowledge of the Clinical Study Process and related working procedures, and understanding of ICH/GCP guidelines.
- Excellent verbal and written communication skills in English.
- Ability to work independently and as part of a team.
- Ability to prepare presentation materials.
- Professionalism and mutual respect.
- Willingness and ability to train others on study administration procedures.
- Excellent organization and time-management skills, attention to detail, and ability to multitask in a high-volume environment with shifting priorities.
Nice To Haves
- A degree in a science or clinical research discipline is preferred.
Responsibilities
- Complete delegated study work in support of Global Study Associate Directors and Global Study Managers, potentially across multiple studies and delivery models.
- Initiate and lead electronic Trial Master File (eTMF) set-up, maintenance, and close-out in accordance with ICH-GCP and AstraZeneca SOPs.
- Provide oversight for non-complex, non-critical-path vendors, ensuring compliance with study requirements and established processes.
- Collaborate with internal staff and external stakeholders to collect regulatory and other essential documents.
- Contribute to electronic regulatory applications and submissions by creating and managing clinical regulatory documents to technical standards and supporting publishing and delivery to regulatory authorities.
- Plan and collate administrative appendices for the Clinical Study Report (CSR).
- Initiate, maintain, and support creation of study documents, ensuring template and version compliance with study-specific requirements.
- Set up, populate, and maintain information in AstraZeneca tracking and communication tools, and support team members in using them.
- Support set-up, maintenance, and close-out of Clinical Trial Transparency (CTT) activity in PharmaCM, coordinating with stakeholders to meet AstraZeneca compliance and regulatory authority needs.
- Support tracking, reconciliation, and follow-up of study budgets and payments, including creating and maintaining purchase orders and running invoice and payment reports.
- Contribute to the application, coordination, supply, and tracking of study materials and equipment.
- Contribute to collection of study supplies at close-out when required.
- Coordinate and oversee administrative tasks and logistical support throughout study conduct, audits, and regulatory inspections in accordance with company policies and SOPs.
- Lead coordination and contribute to preparation of internal and external meetings, including study team, committee, monitor, Investigator, and virtual meetings; liaise with participants and vendors.
- Prepare, contribute, and distribute presentation materials for meetings, newsletters, and websites.
- Work on non-drug process-improvement projects, including leading improvement projects as agreed with the manager.
- Perform other duties as assigned and within the scope of the role.
- Train others on study administration procedures as needed.
Benefits
- Competitive base salary
- Annual bonus
- Long-term incentives
- Generous paid time off
- Comprehensive benefits package
- Qualified retirement program (401(k) plan)
- Paid vacation and holidays
- Paid leaves
- Medical coverage
- Prescription drug coverage
- Dental coverage
- Vision coverage
- Overtime pay for qualifying overtime hours for hourly and salaried non-exempt employees
- Retirement contribution for eligible hourly roles
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
