Senior Associate, Clinical Supply

Pay Rate: $50 - $55 per hour | Location: Redwood City, CA - Hybrid Role

About the Role

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 products and non-investigational medicinal products as per the study protocol.

Responsibilities

• Initiating 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 supplies, and reporting to management
• Identifying and communicating potential risks
• Executing risk mitigation plans
• Attending SMT meetings and 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 the management of IRT systems
• Reporting weekly progress to management

Requirements

• 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, with 2-3 years' experience
• Experience with IRT/IXRS/IWRS required
• Experience in building and managing forecasts for clinical supply chains
• Knowledge of relevant GMPs, GCPs, GDPs, and other regulations
• Excellent computer skills, including Microsoft Suite and outstanding Excel skills

Desired Skills

• Clinical supply chain management
• Clinical trial supplies
• Investigational medicinal products (IMP/IP)
• Non-investigational medicinal products
• TMF file maintenance
• Administrative file management
• Study drug reconciliation
• Clinical supply leadership
• Study management teams
• Supply planning and forecasting
• Inventory tracking and reporting
• Risk identification and mitigation
• Vendor management
• Clinical supply analysis and resupply planning
• IRT, IXRS, IWRS
• Global clinical supply experience
• Regulatory compliance (GMP, GCP, GDP)

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