# Specialist, Global Clinical Solutions (IRT Lead)

**Company**: GCS Services
**Location**: Durham, North Carolina, United States of America
**Work arrangement**: hybrid
**Experience**: entry
**Job type**: full-time
**Category**: Engineering
**Industry**: Healthcare

**Apply**: https://astrazeneca.eightfold.ai/careers/job/563877689867686
**Canonical**: https://yubhub.co/jobs/job_939bf63c-00b

## Description

Role Details

The Specialist, Global Clinical Solutions (IRT Lead) provides global centralized services across drug projects and related activities, helping clinical development programs meet time, cost, and quality expectations across all delivery models.

Key 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.

Essential Skills and Experience

- 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.

- Excellent knowledge of spoken and written English.

- Strong communication skills.

Desirable Skills and Experience

- 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.

## Skills

### Required
- Bachelor's degree
- Pharmaceutical industry experience
- Clinical study delivery/clinical development processes experience
- Organizational and analytical skills
- Multitasking ability
- Time management skills
- Administrative training/experience
- Computer proficiency
- Excellent knowledge of spoken and written English
- Strong communication skills

### Nice to have
- Good understanding of clinical study process
- Programming experience or programming aptitude
- Knowledge of pharmaceutical drug development and clinical study processes and associated government regulations, ICH GCP
- Ability to train others on study support processes and procedures
- Ability to proactively identify risks and issues as well as possible solutions
- GxP trained
