Description

You will support clinical development programs by planning and executing activities for Phase 1-IV and IIS trials, including demand forecasting, budget management, and ensuring compliance with regulations. You'll work cross-functionally with internal teams and external partners to coordinate clinical trial material production and distribution, while mentoring junior colleagues.

Requirements

• Bachelor of Science degree in Health Science (Master's preferred)
• 10+ years of experience in pharmaceutical development focused on clinical trial materials
• Knowledge of GXPs (GMP, GCP, GDP) and regulatory requirements for investigational products
• Proven project management skills
• Ability to handle multiple projects/staff simultaneously
• Understanding of GMP working environments and regulatory guidance (e.g., ICH, 21 CFR Part 11)
• Working knowledge of IRT system build-up and user testing
• Experience in negotiating with customers and suppliers
• Training in clinical trial methodology and Good Clinical Practice
• Excellent organizational and documentation skills
• Excellent written and verbal communication skills
• Ability to travel independently overnight and/or work after hours as required

Responsibilities

• Review and provide feedback during clinical protocol development
• Evaluate total demand and translate into demand forecasts
• Develop clinical supply timelines and initiate procurement procedures
• Regularly review and update inventories and supply plans
• Track expired materials and issue orders for retrieval or disposal
• Investigate and resolve issues regarding inventory, shipments, and returns
• Ensure timely and uninterrupted supply of clinical trial materials
• Support budgets for existing and newly planned projects
• Develop and maintain CTM documentation
• Work with Clinical, Regulatory, and Quality teams on label text and approvals
• Prepare and review contracts, project statements, and batch records
• Reconcile and approve invoices
• Maintain departmental reports and files, update SOPs