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Clinical Operation Supply Manager
AstraZenecaClinical Operation Supply Manager managing clinical trial supplies in China. Supporting study teams and handling customs affairs with a focus on compliance and supply chain efficiency.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Responsible for managing clinical trials supply in China.
- 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.
- 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.
- 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.
- Responsible for clinical supply related external service provider management.
Requirements
What you’ll need- Bachelor degree or above degree in Health Care, or equivalent.
- Minimum 6 years’ experience in Clinical Operations or other related fields, and plus 1 year in clinical supply management area is preferrable.
- Good knowledge of GXP and clinical supply relevant regulations.
- Good knowledge of the Drug Development Process, Study Management, Site Management & Monitoring, and inspections.
- Good conflict and crisis management skills and negotiation skills
- Good ability to prioritize and handle multiple tasks.
- Good communication and cross functional collaboration skills.
- Ability to look for and champion more efficient and effective methods/processes of delivering quality results.
- Fluent in both spoken and written English.
Benefits
Comp & perks- AstraZeneca embraces diversity and equality of opportunity.
- We are committed to building an inclusive and diverse team representing all backgrounds.
- There is no better place to make a difference in medicine, patients, and society.
- A commitment to lifelong learning, growth and development for all.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical supply managementGMPGCPSOP developmentperformance measurement metricscustoms policiesDrug Development ProcessStudy ManagementSite Managementmonitoring
Soft Skills
conflict managementcrisis managementnegotiationprioritizationmultitaskingcommunicationcross functional collaborationproblem solvingtrainingleadership
Certifications
Bachelor degree in Health Care