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.

XML job scraping automation by YubHub

This role builds strong relationships, acts as a key resource and escalation point, and contributes to the creation of strategy for clinical drug supply, translating strategic objectives into clear, actionable plans.

Working both within clinical drug supply and cross-functionally, the Study Supply Manager helps develop consistent practices, routinely identifies risks in the supply chain, recommends mitigation plans to management, and implements effective solutions.

Key responsibilities include:

• Developing and maintaining strong, collaborative relationships with key stakeholders across Global Study Teams, Quality, Radiation Science and CMC, ensuring alignment on study needs and timelines.

• Ensuring key project milestones are met by defining, negotiating and communicating clinical supply plan timelines to internal and external stakeholders and partners.

• Serving as an escalation point to Clinical Logistics, Clinical Operations, CMC and/or CROs, resolving issues quickly and effectively.

• Participating in functional initiatives, including process development and review, and system/process improvement to drive operational excellence.

• Supporting the creation and maintenance of Radioconjugates pharmacy manuals to enable safe and compliant handling at clinical sites.

• Overseeing ordering, tracking, delivery and receipt of clinical supplies and drug to clinical sites, ensuring availability for patients when needed.

• Leading monthly network capacity planning so that supply plans are aligned with clinical programs, manufacturing schedules and quality capabilities.

• Collaborating with Radio Pharm Manufacturing and Quality to manage any issues arising during shipping and/or receipt, communicating delays to the clinical team and, when applicable, managing deviations and corrective/preventive actions.

• Continuously monitoring supply chain risks across multiple programs, proposing mitigation strategies and implementing agreed actions to protect study continuity.

Essential skills and experience include:

• Bachelor’s Degree with 5+ years of experience with clinical supply chain, Phase I-III.

• Knowledge of ICH GCP Guidelines and local and international regulatory requirements.

• Demand planning, forecasting and analytical skills.

• Advanced problem-solving ability.

• Flexibility in working hours to deal with Global supply activities.

• Excellent written, verbal and interpersonal communication skills and comfort working with multiple internal and external stakeholders.

Desirable skills and experience include:

• Certification in Supply Chain and Operations Management (i.e. – CSCP, CPIM).

• Prior experience in radiopharmaceutical/pharmaceutical product distribution of Class 7 Dangerous goods including import/export.

XML job scraping automation by YubHub