Sr. Manager/Manager, Clinical Supplies

W2 Contract

Pay Rate: $60 - $85 per hour

Location: Redwood City, CA - Hybrid Role

Job Summary:

The Clinical Supply Manager is responsible for the supply strategy and management of clinical trial supplies for the company. This position will report to Clinical Operations and will partner with Clinical Supply Chain to ensure adequate clinical supplies from study initiation through completion. Clinical trial supplies include investigational medicinal products and non-investigational medicinal products as per the study protocol.

Duties and Responsibilities:

• Ensuring adequate clinical trial supplies are available for each study.
• Acting as the clinical supply lead for each Study Management Team (SMT).
• Managing, forecasting, ordering, and tracking of supplies.
• Identifying and communicating potential risks, defines, and executes risk mitigation plans.
• Overseeing daily CMO activities[JM2] from DP release to study close-out.
• Attending SMT meetings and external vendor teleconferences.
• Communicating supply plans effectively.
• Communicating levels of clinical trial material and impact on clinical supply.
• Participating in the management of IRT systems.
• Reporting to management.Desired Clinical Supply Skills:
• Planning sufficient inventory supply and managing adequate levels.
• Understanding of GMP manufacturing and IP release processes.
• Managing a CMO (labeling/distribution) vendor.
• Identifying and communicating constraints effectively.
• Tracking various supply chain activities.
• Problem-solving supply chain constraints.
• Providing input into user requirement specifications of Interactive Response Technology (IRT) medication management module(s) as needed.
• Reviewing the IRT dispensation strategy to ensure it supports supply plans.
• Ensuring that IRT settings are optimized based on projections.
• Executing IRT User Acceptance Testing.
• Leveraging the inventory management capabilities of the IRT and other data sources for reporting.
• Devising and implementing inventory management plans.
• Creating, reviewing, implementing, and maintaining IP forecasts.
• Collaborating with the Clinical Operations Team on annual and periodic projections/reviews.
• Managing IP distribution in partnership with Clinical Operations team members and the vendor.
• Proactively identifying potential supply chain issues to recommend solutions.
• Creating and maintaining inventory and demand trackers utilizing IRT and other data sources.
• Monitor consumption and schedule shipments to resupply regional depots.
• Updating inventory and demand slides for individual SMT meetings.
• Developing and maintaining metrics for management to review.
• Co-leading planning, labeling, and distribution meetings.
• Scheduling ad-hoc shipments for non-IRT-managed studies.
• Other, based on current needs.

Requirements and Qualifications:

• Bachelor's degree or higher in operations management or a science-related field (equivalent work experience may be considered).
• Minimum of 4-5 years clinical supply chain management experience, global experience is preferred.
• Strong Project Management Skills, 2-3 years' experience.
• Experience with IRT/IXRS/IWVR required.
• Experience in building and managing forecasts for clinical supply chains.
• Knowledge of relevant GMPs, GCPs, GDPs, and other regulations.
• Excellent computer skills, Microsoft Suite.
• Outstanding Excel skills are a plus.

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as Inc.'s candidate.

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