Specialist, Global Clinical Solutions - IRT at AstraZeneca

Durham, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

21 Mar, 26

Salary

115855.2

Posted On

21 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Organizational Skills, Analytical Skills, Communication Skills, Training, Vendor Management, Data Integrity, Regulatory Compliance, Process Improvement, Clinical Study Processes, Problem Solving, Multitasking, Time Management, Lifecycle Management, User Enablement, Knowledge Sharing

Industry

Pharmaceutical Manufacturing

Description

Specialist, Global Clinical Solutions As part of Global Medicines Development (GMD), Clinical Operations is accountable for delivering clinical studies. Global Clinical Solutions (GCS) enables this mission by providing industry-leading processes, technology, and centralized services that help Clinical Operations and its partners deliver development programs to time, cost, and quality. The GCS Specialist supports high-quality, complete operational data, robust lifecycle management of systems and processes, and effective training and adoption across user communities. We are recruiting IRT Leads to oversee our Interactive Response Technology (IRT)/ Randomization & Trial Supply Managment (RTSM) systems that manage randomization, drug supply, and site/subject activities for clinical studies. In this role, you will support study teams through the full lifecycle—set-up, maintenance, and close-out—of the IRT system tailored to each clinical protocol. You will drive vendor management, ensuring performance, quality, compliance, and timely delivery across IRT providers. Successful candidate requires emerging project management skills—we expect you to bring at least one (e.g., planning, risk/issue tracking, or stakeholder communication) and show strong willingness to learn and develop the others. Impact: This role safeguards data integrity and regulatory readiness, streamlines operational processes and tools to accelerate study delivery, and strengthens user capability and adoption across Clinical Operations. Key responsibilities: Service delivery across drug projects: ensure consistent, complete, and high‑quality Clinical Operations data; partner with Study Teams and external vendors. Systems and tools enablement: set up, maintain, validate, and test Clinical Operations systems/tools; manage lifecycle, business continuity, standards, and procedural/system documentation. Training and user enablement: deliver process/system/tool trainings; facilitate knowledge sharing; establish best practices and support effective communication within Clinical Operations. Process excellence and improvement: analyze usage to identify efficiency and effectiveness opportunities; contribute to user requirements and UAT; support business cases for continuous improvement. Change participation: contribute to change initiatives related to Clinical Operations. Essential qualifications: Bachelor’s degree and 2+ years of experience. Strong organizational and analytical skills; proven multitasking and time management. Computer proficiency; excellent spoken and written English; strong communication skills. Demonstrated alignment with AZ Values and Behaviours. Prior administrative training/experience. Desirable qualifications: Degree in biological sciences or a healthcare-related field. Understanding of clinical study processes and pharmaceutical development; knowledge of regulations (ICH GCP); GxP training. Experience in pharma or clinical development environments. Ability to train others on study support processes and proactively identify risks/issues and solutions. The annual base pay for this position ranges from $77,236.80 - $115,855.20. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Date Posted 19-Dec-2025 Closing Date 30-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.

Responsibilities

The Specialist will oversee the IRT/RTSM systems for clinical studies, ensuring high-quality operational data and effective vendor management. They will support study teams throughout the full lifecycle of the IRT system tailored to each clinical protocol.