Job Description

Senior Associate, Clinical Supply

W2 Contract

Salary Range: $93,600 - $114,400 per year

Location: Redwood City, CA - Hybrid Role

Job Summary:

The Clinical Supply Senior Associate is responsible for the 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 product, and non-investigational medicinal product as per study protocol.

Duties and Responsibilities:

• Miniating TMF files for current and past studies
• Performing administrative file management
• Performing study drug (IP) reconciliation
• Acting as the clinical supply lead for each Study Management Team (SMT).
• Managing, forecasting, tracking of supplies, and reporting to management
• Identifying and communicating potential risks
• Executing risk mitigation plans
• Attending SMT meetings, external vendor teleconferences
• Executing on supply plans effectively
• Communicating inventory levels of clinical trial material to management
• Analyzing clinical supply and proposing resupply dates and volumes
• Participating in management of IRT systems
• Reporting weekly progress to management
• Providing input into user requirement specifications of Interactive Response Technology (IRT) medication management module(s) as needed.
• Reviewing 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.

Requirements and Qualifications:

• Bachelor's degree or higher in operations management or 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 required
• Providing input into user requirement specifications of Interactive Response Technology (IRT) medication management module(s) as needed.
• Reviewing 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.

Desired Skills and Experience

TMF, Clinical, GMP, GCP, GDOP, IRT, IXRS, IWVR, Clinical Supply Chain, Microsoft Office, Excel

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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