Manager, Global Clinical Solutions

AstraZeneca•Durham, NC

About The Position

Manager, Global Clinical Solutions Introduction to role 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. This role supports cross-functional teams in improving process effectiveness and performance, while providing guidance on the design, development, and maintenance of processes, systems, and services owned by GCS. Managers may be assigned stewardship of specific processes or platforms and are expected to lead and project manage continuous improvement initiatives that enhance operational outcomes, strengthen compliance, and optimize ways of working across diverse delivery models.

Requirements

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 organizational and analytical skills, and proven skills to deliver to time, cost and quality
Proven project management proficiency
Strong business communication, stakeholder management and presentation skills
Well-developed organizational and interpersonal skills
Ensures risks and issues management to ensure effective delivery.
Expertly utilizes escalation routes and governance to gain traction and deliver rapid solutions
Shares lessons learned and best practice recommendations with relevant stakeholders to drive continuous improvement
Builds relationships and achieves results without line management input

Nice To Haves

Experience applying 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 ICH GCP guidelines in relation to study delivery
Experience working in a global organization with complex/geographical context

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. This includes 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
Serve 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.
Coordinate input to eCOA/DPS user requirements (from Business Analyst and study stakeholders) based on the Clinical Study Protocol (CSP) and prior end‑user experience; agree system functionality with suppliers.
Lead operational maintenance to keep systems aligned to the latest CSP and in a validated state; author and manage change requests with risk assessment and ensure issues are documented and addressed.
Establish UAT approach for setup and maintenance; request UAT resources; consult 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