Introduction: Global Clinical Solutions (GCS) delivers services and technology that enable AstraZeneca's Clinical Development programs, partnering with internal teams and external stakeholders to drive operational excellence. The Manager, GCS is responsible for coordinating and leading the delivery of GCS services across projects and initiatives to meet time and quality targets.

Key Responsibilities:

• Coordinates and delivers GCS services and coordinates life cycle management and business continuity for projects services and technology.
• Provides expert support to user communities, including conducting training on processes, systems, and tools, facilitating information exchange, establishing proven methods, and maintaining communication with relevant parties across GCS and AZ.
• Conducts critical analyses of processes and tools to define business usage and finds opportunities to improve efficiency/effectiveness of systems/services/processes whilst reducing business continuity risks.
• Contributes to and/or develops business cases for continuous improvement projects.
• Leads or manages business improvement projects according to lean principles, including planning, prioritizing, implementing and tracking delivery.
• Serves as AZ co-Project Manager for eCOA (electronic Clinical Outcome Assessment) and DPS (Digital Patient Solutions) setup, maintenance, and closure, using project tracking tools to manage timelines, costs, risks, UAT, and stakeholder updates.
• Coordinates input to eCOA/DPS user requirements (from Business Analyst and study stakeholders) based on the Clinical Study Protocol (CSP) and prior end-user experience; agrees system functionality with suppliers.
• Leads operational maintenance to keep systems aligned to the latest CSP and in a validated state; authors and manages change requests with risk assessment and ensures issues are documented and addressed.
• Establishes UAT approach for setup and maintenance; requests UAT resources; consults on test scripts, plans, reports, and change closure documentation.
• Supports the implementation of changes to improve the way various functions and teams perform.
• Evaluates and monitors the performance and efficiency of programs to ensure that program implementation is on target.
• Responsible for training colleagues to use continuous improvement in the new ways of working and embed change culture.
• Grows capabilities, applies new approaches to improve work and has positive impact on team performance creating learning opportunity for others.
• Responsible for knowledge management of continuous improvement activities and ensuring that the knowledge is used in the selection and execution of future activities.

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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.

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The Manager, GCS supports teams to improve process effectiveness and performance and provides guidance in the development and maintenance of processes, systems and services owned by GCS.

This role coordinates, leads and delivers GCS services across projects and activities, ensuring operational excellence across all delivery models.

It also leads and project manages improvement initiatives that strengthen how clinical development is delivered and how patients ultimately benefit from our science.

As a key member of an activity team, the Manager, GCS coordinates and delivers GCS services, overseeing lifecycle management and business continuity for assigned projects, services and technologies.

The role provides expert support to user communities by conducting process, system and tool training, facilitating knowledge sharing, establishing best practices and maintaining clear communication with stakeholders across GCS and AstraZeneca.

It involves conducting critical analyses of processes and tools to define business usage, identifying opportunities to improve efficiency and effectiveness while reducing business continuity risks, and contributing to or developing business cases for continuous improvement projects.

The Manager, GCS leads or manages business improvement projects using lean principles, including planning, prioritising, implementing and tracking delivery.

Acting as a source of knowledge in one or more GCS areas, the role supports the implementation of changes that enhance how functions and teams perform.

It evaluates and monitors programme performance to ensure implementation stays on target, trains colleagues in continuous improvement and new ways of working, and helps embed a culture of change.

The role grows capabilities, applies new approaches to improve work, positively impacts team performance and creates learning opportunities for others.

It is also responsible for knowledge management of continuous improvement activities, ensuring insights are captured and used to shape future initiatives.

Ready to help transform how clinical development operates?

Essential Skills/Experience:

• BS, MS, or PhD in a biological or healthcare-related field with 2+ years of relevant pharmaceutical or clinical development industry experience

• Ability to work collaboratively; proven organisational and analytical skills, and proven skills to deliver to time, cost and quality

• Good project management skills

• Excellent knowledge of spoken and written English

• Strong business communication, stakeholder management and presentation skills

• Well-developed organisational and interpersonal skills

• Ensure risks and issues management to ensure effective delivery.

Expertly utilises escalation routes and governance to gain traction and deliver rapid solutions

Share lessons learned and best practice recommendations with relevant stakeholders to drive continuous improvement

Build relationships and achieve results without line management input

Curious and self-motivated

Desirable Skills/Experience:

• Experience utilising standard process improvement methodologies (e.g. Lean Six Sigma) to identify root causes of process issues and identify areas of process improvement

• Some experience with Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment

• Experience in multiple fields of clinical development

• Understanding of ICH GCP guidelines in relation to study delivery

• Experience working in a global organisation with complex/geographical context

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 the chance to follow the science end-to-end, from early discovery through late-stage development, in an environment where digital, data science and AI are embedded into everyday work.

Colleagues collaborate across disciplines and geographies to tackle complex diseases, learn from patients' experiences and translate ideas into life-changing medicines for people worldwide.

Continuous learning is encouraged through diverse projects, development programmes and exposure to different therapy areas, enabling meaningful careers built on curiosity, courage and scientific excellence.

If this role matches your skills and ambition, apply now to help shape the future of clinical development and make a real impact for patients!

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