- 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.
- 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
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Director of Clinical Supply Chain - California, United States - Mix Talent
2 weeks ago
Description
We are currently looking for a Director of Clinical Supply Chain who will be responsible for inventory planning and management of clinical supplies throughout all phases of a clinical study. This individual will need to work cross-functionally, adhere to timelines, manage within budget, and ensure that all required SOPs, GMPs, and regulatory requirements are met.
SUMMARY OF DUTIES AND RESPONSIBILITIES:
Qualifications
According to the position's primary location, the salary range for this role is expected to be between $170,000 and $200,000 USD per year. The actual pay will be decided based on the candidate's experience, qualifications, geographical location, and other job-related factors as permitted by law. This position is also eligible for benefits.
Job Identifier: #4547