Supply Chain Director
4 days ago
We are seeking a Clinical Supply Chain Manager or Director who will work cross-functionally and be responsible for planning and managing inventory of clinical supplies throughout the start-up, execution, and close-out phases of a clinical study. The manager/director will need to adhere to timelines, stay within budget, and ensure that all SOPs, GMPs, and regulatory requirements are met.
SUMMARY OF DUTIES AND RESPONSIBILITIES:
This individual will act as the point of contact for clinical supplies at the study level.
Manage and adjust campaign strategies and inventory management systems, including IVR, IWR, and IRT.
Assess the clinical study enrollment rates and ensure supply planning supports study enrollment needs.
Responsible for conducting issue resolution activities for supply aspects of clinical studies, which could include Product Quality Complaints/ Events, Temperature Excursions, and Logistic Events
Manage label creation, Clinical Supply Plans, and relabeling activities.
Collaborate with biostats and quality to obtain randomization lists to ensure timely upload into the inventory management system.
Oversee clinical supply vendors, including depots and third-party vendors.
Ensure an audit-ready clinical trial package and all required documentation.
Identify and implement improvements impacting specific studies/compounds.
Modify, as needed, supply strategies in view of changes in study execution and ensure a seamless transition from study design phase.
Utilize business tools (e.g., IVRS) to manage inventories at depots and sites and ensure on-time delivery with minimal overage of clinical supplies.
Develop and maintain strong internal collaboration with stakeholders to ensure supply needs are met
Interface for clinical supplies with Clinical Project Managers/Clinical Trial Managers/CMC.
Manage study clinical supplies budget.
Participate in audits of depots and review of audit reports, as applicable.
LOCATION
Onsite, Los Altos, California Office-Based.
Qualifications
A minimum of a bachelor’s degree and four years of experience in clinical supplies or a related supply chain role (supply or demand planning).
General knowledge of GxP principles is required.
Intermediate to advanced Microsoft Excel and PowerPoint software skills are required.
The successful candidate will have solid data analysis and problem-solving experience
Based on the primary location, the expected salary range for this position is $170,000 to 200,000 USD annually. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for the benefits.
Job Identifier: #4547
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