Director, Clinical Trial Materials

Role Summary

Director, Clinical Trial Materials

Responsibilities

• Review and Interpretation of a clinical protocol or study overview:
  • Review and provide feedback during the development of the clinical protocol.
  • Evaluate total demand and translation of total demand into a demand forecast.
  • Interface with Project Managers to develop clinical supply timelines, obtain study overviews and drug requirements, and initiate procurement procedures.
  • Regularly reviews and updates inventories and supply plan against Clinical forecasts including all supply related information such as lot numbers, current status, and kit genealogy and expiration date extension.
  • Tracks expired materials and issues orders for retrieval or disposal.
  • Be proficient with current inventory and tracking systems by learning their usage, updates and maintenance.
  • Challenges current processes, practices and strategies
  • Provides innovative solutions to complex issues and consistently evaluates opportunities for improvement.
  • Investigates and resolves issues regarding inventory, shipments and returns.
  • Responsible for end to end, full CTM lifecycle, ensures that all clinical trials have timely and an un-interrupted supply of CTM.
  • Provides and supports budgets for existing and newly planned Projects.
• Supports CTM activities with Clinical Supply Packagers and Distributors, Technical Services, Clinical R&D staff, Project Teams, IT/IS, Data Management, CROs and other sites and departments as necessary
• Develops and maintains CTM documentation necessary to support company policies, procedures and all regulatory guidelines
• Works with Clinical, Regulatory and Quality teams in preparing label text, obtaining translations and approval of label proofs
• Works collaboratively with Vendors to optimize relationships and build confidence.
• Prepares and reviews applicable contracts, project statements, change orders, packaging requests, and batch records for accuracy and completeness
• Reconciles and approves invoices
• Prepares reports to ensure accuracy and completeness of clinical supplies information. Maintains departmental reports and files, updates SOPs and other projects as assigned

Qualifications

• Minimum Bachelor of Science degree (BS) in Health Science (preferred Master of Science degree). Equivalent combination of relevant education and applicable job experience may be considered with at least 10+ years of experience in pharmaceutical development focused on clinical trial materials
• The individual must be well versed in GXPs (GMP, GCP, and GDP) and as well as other regulatory requirements as they pertain to investigational products
• Proven project management skills
• Develops team building and training of staff to support Team skills and enhance operational effectiveness
• Ability to handle multiple projects/staff simultaneously
• Excellent understanding of GMP working environments and regulatory guidance and regulations (e.g., ICH, 21 CFR Part 11)
• Excellent understanding and working knowledge of IRT system build-up and user testing
• Experienced in negotiating skills with customers and suppliers
• Hands on training and experience in clinical trial methodology and Good Clinical Practice
• Excellent organizational and documentation skills
• Demonstrated track record of ability to self-direct and resolve issues with the vendors, CRO staff and internal teams
• Excellent written and verbal communication skills
• Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization
• Skilled at creating a cooperative team environment
• Able to objectively evaluate situations and make recommendations for changes in light of overall project demands

Skills

• GXP/GMP/GCP/GDP knowledge
• Project management
• Inventory and CTM lifecycle management
• Labeling, translations, and regulatory compliance
• Vendor, CRO, and cross-functional collaboration
• IRT system knowledge
• Documentation, reporting, and process improvement

Education

• Bachelor of Science in Health Science (required); Master of Science preferred

Additional Requirements

• Travel as required by business needs
• Regular standing, walking, sitting, and handling or operating equipment; ability to lift up to twenty pounds