Specialist, Global Clinical Solutions - IRT

Clinical Operations within Global Medicines Development (GMD) is accountable for the delivery of clinical studies.

Global Clinical Solutions (GCS) drives the delivery of Business Process Excellence and Technology for organisation, owning and providing industry leading process, technology and services on behalf of Clinical Operations and its internal and external Partnerships.  

The GCS Specialist is a member of the Global Clinical Solutions Team, and is Actively support Clinical Operations by ensuring the population and availability of complete, high quality data from Clinical Operations processes and systems. Deliver Clinical Operations processes and systems trainings and participate in the coordination of the life cycle management of processes and systems/tools including associated documentation (procedural, system). Deliver global centralized services across drug projects and/or other activities that enable delivery of Clinical Development programs to time, cost, and quality across all delivery models.

Individuals in this job may be assigned one or more roles relating to the development and maintenance of Enablement processes, systems and services owned by GMD Clinical Operations.

Operational Activities

As the member of a specific activity team :

• Delivers GCS services across drug projects
• Sets up and maintains systems/tools and data associated with Clinical Operations enabling services in partnership with Study Teams and external partners to appropriate standards, completeness, quality and consistency
• Supports life cycle management and business continuity for Clinical Operations processes, systems/tools, standards, procedural documentation and training materials,
• Provides support to user communities including
  • conducting relevant process/system/tool trainings
  • facilitating knowledge sharing
  • establishing of best practice
  • ensuring communication within Clinical Operations
  • Performing validation and testing of processes and systems
• Performs analyses of Clinical Operations processes and tools to define business usage and identify opportunities to improve efficiency/effectiveness of systems/methods/processes; Support in User Requirement Specifications and User Acceptance Tests
• Contributes to business cases for continuous improvement project
• Participates in change initiatives relating to Clinical Operations.

Essential

• Bachelor’s degree or other equal education that supports Skills and Capabilities of the position and ensures successful conduct of accountabilities/responsibilities and appropriate interactions with internal/external customers
• Proven organizational and analytical skills
• Proven ability to multitasking, time management and have task oriented performance
• Previous administrative training/experience
• Computer proficiency
• Excellent knowledge of spoken and written English
• Strong communication skills
• Exhibit of AZ Values and Behaviors.

Desirable

• University degree in biological science or health care related field
• A good understanding of the clinical study process
• Work experience in the pharmaceutical industry or in the environment of clinical study delivery/clinical development processes
• 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