Position Summary:

In support of clinical development programs, the Senior Manager of Clinical Trial Materials role oversees Clinical Trial Material (CTM) planning and execution activities, supporting Phase 1-IV and IIS trials. Includes demand forecasting, determination of an appropriate presentation, setting production schedules, protocol review, ensures label compliance with applicable regulations, establishes optimal packaging & distribution strategies, tracks and reconciles drug supplies and monitors product re-test dates. Interface with internal departments and contract research organizations (CROs) as necessary to coordinate the execution of these activities. Implements and ensures group compliance to procedures for the production and distribution of investigation product. Mentor junior colleagues in the CTM team as required.

Primary Responsibilities:

• Review and Interpretation of a clinical protocol or study overview:
  • Review and provide feedback during the development of the clinical protocol.
  • Calculate 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.
  • Periodically reviews and updates inventories 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.
  • Proposes and implements improvements to assure efficient clinical supply operations.
  • 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.
• Coordinates 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
• 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

Education/Experience/Skills

• 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 4-6 years' 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
• Ability to handle multiple projects simultaneously
• Good understanding of GMP working environments and regulatory guidance and regulations (e.g. ICH, 21 CFR Part 11)
• Good understanding of IRT system build-up and user testing
• Good negotiating skills with customers and suppliers
• Hands on training and experience in clinical trial methodology and Good Clinical Practice
• Good 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

Physical Requirements:

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

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