Specialist, Global Clinical Solutions (IRT Lead)

AstraZeneca • Durham, NC

2d • Hybrid

About The Position

Specialist, Global Clinical Solutions (IRT Lead) Introduction to role Global Clinical Solutions (GCS) delivers services and technology that underpin clinical development across AstraZeneca. The Specialist, GCS provides global centralized services across drug projects and related activities, helping clinical development programs meet time, cost and quality expectations across all delivery models. The role ensures complete, high-quality data from clinical operations processes, procedures and systems, supports and sometimes delivers training on system procedures and processes, and contributes to the coordination of life cycle management for processes, systems and tools, including associated documentation. Specialists, GCS also participate in improvement projects and contribute to functional and regional initiatives that push our science forward. Ready to help turn complex data and processes into real impact for patients? Accountabilities Deliver GCS services that support clinical development activities across multiple projects and stakeholders. Set up and maintain systems, tools and data associated with projects, services and technology in partnership with Study Teams and external partners, ensuring appropriate standards, completeness, quality and consistency. Support life cycle management and business continuity for operational processes, procedures, systems, tools, standards, procedural documentation and training materials. Provide support to user communities by conducting relevant process, system and tool trainings, facilitating knowledge sharing, establishing best practice and maintaining effective communication with stakeholders across GCS and AstraZeneca. Perform analyses of processes and tools to define business usage and identify opportunities to improve efficiency and effectiveness of systems, methods and processes; support the development of User Requirement Specifications and User Acceptance Tests. Contribute to business cases for continuous improvement projects that enhance how we deliver clinical studies. Prioritize workload effectively to achieve personal and work unit targets in a dynamic environment. Participate in change initiatives that evolve our ways of working and enable better outcomes for patients. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. AstraZeneca offers an environment where science, data and technology come together to tackle some of the world’s most complex diseases, from early discovery through late-stage development. Here, curiosity is encouraged, diverse perspectives are valued, and collaboration with academia, biotechs and industry partners helps accelerate breakthroughs that can reach patients faster. With access to cutting-edge tools, a strong pipeline and many opportunities to learn new skills, this is a place to build a meaningful career while contributing to life-changing medicines for patients worldwide. If this role matches your skills and ambitions, apply now to join us on this journey!

Requirements

• Bachelor’s degree with 0+ years of work experience in the pharmaceutical industry or in clinical study delivery/clinical development processes
• Proven organizational and analytical skills, as well as proven ability to multitask
• Strong time management skills and task-oriented performance
• Previous administrative training/experience
• Computer proficiency
• Can create and maintain systems for efficiency for self and others
• Excellent knowledge of spoken and written English
• Strong communication skills
• Exhibit of AZ Values and Behaviors

Nice To Haves

• A good understanding of the clinical study process
• Programming experience or programming aptitude
• Knowledge of pharmaceutical drug development and clinical study processes and associated government regulations, ICH GCP
• Shown willingness and ability to train others on study support processes and procedures
• Demonstrate the ability to proactively identify risks and issues as well as possible solutions
• GxP trained

Responsibilities

• Deliver GCS services that support clinical development activities across multiple projects and stakeholders.
• Set up and maintain systems, tools and data associated with projects, services and technology in partnership with Study Teams and external partners, ensuring appropriate standards, completeness, quality and consistency.
• Support life cycle management and business continuity for operational processes, procedures, systems, tools, standards, procedural documentation and training materials.
• Provide support to user communities by conducting relevant process, system and tool trainings, facilitating knowledge sharing, establishing best practice and maintaining effective communication with stakeholders across GCS and AstraZeneca.
• Perform analyses of processes and tools to define business usage and identify opportunities to improve efficiency and effectiveness of systems, methods and processes; support the development of User Requirement Specifications and User Acceptance Tests.
• Contribute to business cases for continuous improvement projects that enhance how we deliver clinical studies.
• Prioritize workload effectively to achieve personal and work unit targets in a dynamic environment.
• Participate in change initiatives that evolve our ways of working and enable better outcomes for patients.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees