Clinical Supply Associate
The Clinical Supply Associate_Temperature Management is a role responsible for providing support to clinical supply chain group in executing supply strategies matching the needs of clinical programs and trials to ensure on-time delivery and optimal supply coverage for API, DP, and packaged materials with a specific focus on Temperature Management & Control. This position will be located in Shanghai.
• Act as Clinical Supply Chain Co-Ordinator for assigned projects and help orchestrate all clinical supply activities to successfully deliver a clinical program in coordination with other Clinical supply functions.
• Participate in sub-team and CS&OP meetings and contribute to resolving critical risks and issues, including communication with key stakeholders. Assist in developing and executing a well-designed integrated demand and supply plan from API to Kit.
• Support GCP and GMP health authority inspections from temperature management & control perspective.
• Handle Temp Excursions:
Ø Handles all temperature excursions associated to clinical supplies during trial feasibility and throughout trial execution for all phases of clinical trials. Acts as the first point of escalation in case of issues.
Ø Ensure prompt resolution and compliance with all SOP, GMP, Quality, and Regulatory guidelines, positively influencing successful subject dosing
• Develop strong internal collaboration with the broader CSC organization (i.e. Clinical Supply Integrator, Trial & Supply Management, Logistics), and cross-functional business partners (i.e. Global Clinical Operations, Drug Product Development, Analytical Development, Quality) to execute temperature management processes.
Profile needed for this function
• Experience in at least one of the following areas: Clinical Supply Distribution, Clinical Study Execution, supply chain operations, planning, logistics, quality, regulatory, pharmaceuticals research & development.
• General knowledge of GxP principles is required
• Excellent written and verbal communication skills, able to communicate clearly, making the complex clear and compelling to all levels of the organization in both written & oral forms are required
• Ability to work in a high-pressure environment, acts with speed, flexibility, and accountability to achieve goals is required
• Proven success in operating as part of a team with shared workload
• Experience working with remote teams.
• A minimum of a bachelor’s degree in a scientific/technical/medical-related major is required, master degree is preferred.
• A minimum of two (2) years of professional related business experience is required, previous R&D experience with a clinical supply focus in MNC is preferred
• Chinese, Fluent in written and spoken English
Specific know how of systems
• Strong cross-functional coordination skills
• Excellent problem solving and decision-making skills
• Strong quality management skills and experience with quality system tools
• Requires strong MS Office proficiency, specifically advanced Microsoft Excel, SharePoint, and PowerPoint skills)
• Proactively work others in completing data analyses and develops results-oriented conclusions
• Business applications experience is an advantage, such as SAP Ariba and/or Interactive Response Technology (i.e. IVRS) functionality
• Experience with clinical supply demand management tools (e.g. IVRS, SAP, OMP+) is preferred