Clinical Operation Supply Manager

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 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 result.
• Fluent in both spoken and written English.
• Good ability to learn and to adapt to work with IT systems.

Desirable:

• Manages change with a positive approach to the challenges of change for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
• Ability to work in an environment of remote collaborators.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.