AstraZeneca
ClinicalOperationSupplyManager
Neural analysis suggests this role is
optimal for Manager candidates.
“Clinical Operation Supply Manager at AstraZeneca. Skills: Clinical supply management, Customs Affaires, Cross-functional collaboration. Manage clinical trials supply. Provide support to study team”
What You'll Achieve.
Deliver within agreed timeline; Deliver with good quality; Ensure smooth clinical trial conduct; Enable clinical operation excellence
Industry & Context.
Issue resolution; Problem solving
What They're Looking For.
Must Have
Bachelor degree or above, Minimum 6 years’ experience, 1 year clinical supply management, Good knowledge of GXP, Good knowledge of regulations, Good knowledge of Drug Development, Good knowledge of Study Management, Good knowledge of Site Management, Good knowledge of inspections, Good conflict management skills, Good crisis management skills, Good negotiation skills, Ability to prioritize, Handle multiple tasks, Good communication skills, Good cross functional collaboration, Ability to look for efficient methods, Ability to look for effective methods, Fluent in spoken English, Fluent in written English, Ability to learn IT systems, Ability to adapt to IT systems
Nice to Have
Manages change positively, Sees change as opportunity, Work in remote environment
What You'll Do.
Manage clinical trials supply
Provide support to study team
Define clinical supplies plan
Ensure study drug delivery
Ensure clinical devices delivery
Manage clinical supply budget
Handle issues raised by study team
Manage Customs Affaires activities
Build engagement with Customs Affaires
Build collaboration with Customs Affaires
Communicate with Customshouse
Facilitate importation
Facilitate exportation
Drive cross function discussion
Drive collaboration to solve Customs issues
Provide instructions to AZ internal team
Provide trainings to AZ internal team
Maintain compliance with GMP
Maintain compliance with GCP
Maintain compliance with AZ SOP
Maintain compliance with laws
Maintain compliance with regulations
Develop clinical supply SOPs
Update clinical supply SOPs
Develop robust working tools
Establish performance metrics
Evaluate clinical supply performance
Identify improvement areas
Support study team solve issues
Take lead role to solve major issue
Resolve across studies issues
Manage external service providers
Oversee services in clinical trial
How You'll Work.
Team & Collaboration
China study team; Cross function discussion; Multiple parties; Global Clinical Supply; Clinical site; Service providers; Procurement function
Communication Scope
Cross functional communication; Customshouse communication
Full Job Description
Typical Accountabilities * Responsible for managing clinical trials supply in China and providing strong support to China study team, including defining clinical supplies plan of re-packaging and label design, ensure study drug and clinical devices could be delivered within agreed timeline and with good quality, managing clinical supply related budget, monitoring and handling issues raised by study team. * Responsible for management of Customs Affaires related activities and building up strong engagement and collaboration with Customs Affaires. Communicate with the Customshouse and facilitate importation and exportation, drive cross function discussion and collaboration to solve the Customs related issues. Act as Subject Matter Expert (SME) on customs policies and processes and responsible for providing instructions and trainings to AZ internal team, when necessary. * Responsible for maintaining good level of compliance with GMP, GCP, AZ SOP and related laws and regulations. Responsible for clinical supply related SOPs development and updating, as well as robust working tools. Establish performance measurement metrics for holistic clinical supply performance evaluation, identify potential improvement areas and drive necessary optimization accordingly. * Support study team solve clinical trial supply related issues or take the lead role to solve major issue where efforts from multiple parties are required. Responsible for across studies issue resolution, including issues related to Global Clinical Supply, clinical site and service providers, so to ensure smooth clinical trial conduct and enable clinical operation excellence. * Responsible for clinical supply related external service provider management. Act as Subject Matter Expert (SME) from DevOps function, work with procurement function to maintain proper clinical supply pool, manage interaction with service providers and oversee services in clinical trial. Essential: * Bachelor degree or above degree in Health Ca
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