Clinical Supply Manager
hace 5 días
Rochester
Kelly Science & Clinical is seeking a Clinical Supply Manager near Rochester, NY. Contract to hire Shift: Monday - Friday 8am-5pm Compensation: $40-$50/hour DOE Hybrid schedule Position Overview: The Manager, Clinical Supply will be responsible for the comprehensive management and oversight of all clinical supply activities for pharmaceutical and medical device clinical studies. This role ensures the successful planning, forecasting, sourcing, packaging, labeling, distribution, and reconciliation of clinical supplies, while maintaining compliance with regulatory standards and supporting clinical trial objectives. Key Responsibilities: • Lead and manage clinical supply planning, procurement, packaging, labeling, and distribution for clinical trials., • Collaborate with cross-functional teams to develop clinical protocols and supply plans, including treatment group schemes, study materials, packaging design, label text, and distribution strategies., • Coordinate internal processes for secondary labeling, packaging, inventory management, and depot distribution., • Liaise with external vendors for clinical labeling, packaging, and distribution, including negotiation and oversight of contracts and purchase orders., • Partner with Clinical Operations, Regulatory Affairs, and Translation Services to develop and review label copy requirements for clinical trial materials., • Work closely with Statisticians and Data Management teams to facilitate the randomization and preparation of clinical supply kits/medication lists., • Collaborate on Randomization and Trial Supply Management (RTSM) system setup, including User Acceptance Testing (UAT)., • Oversee clinical supply budget planning, forecasting, and spend reconciliation., • Participate as an active member of the Laboratory Control and Compliance Team, ensuring adherence to SOPs and regulatory requirements., • Develop, implement, and maintain Standard Operating Procedures (SOPs) related to clinical supply management., • Manage the reconciliation, destruction, and proper disposition of clinical trial materials at study completion., • Support continuous process improvement and best practice adoption within clinical supply operations. Work Arrangement: This position is primarily on-site, with the flexibility to work remotely on occasion. Preferred Qualifications: • Bachelor’s degree in a scientific, technical, or related field., • Strong interpersonal and communication skills., • Ability to manage multiple priorities in a fast-paced environment., • Solid understanding of clinical trial procedures and supply chain management., • Experience collaborating with cross-functional teams and external vendors., • Excellent organizational and project management abilities.