Consultant Clinical Trial Supply CTS Study Manager

Profile

 SUMMARY:

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This consultant position would assist the project team with all activities pertaining to Clinical Trial Supply (CTS) across multiple drug development products.

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RESPONSIBILITIES:

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Areas of support would include the following:

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Provide day to day CTS expertise and project management support to various clinical programs.

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Track and manage project timelines and facilitate communications between key stakeholders.

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Provide end-to-end supply chain management for clinical trial supplies (packaging, labeling, IRT, distribution).

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Independently leads clinical studies to ensure compliant, on-time supply of study medication and ancillary materials for patients.

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Manage kit design and blinding, manage the packaging process (vendor selection/oversight, batch reviews, etc.), review and approve labelling batch records.

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Manage all IRT activities (vendor selection/management/oversight).

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Forecast demand of investigational product and ancillary supplies, establishing, and managing the depot network and distribution to clinical sites, and ensuring final return and destruction. 

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Also responsible for day-to-day CMC project management support, tracking and managing project timelines, and leads process improvement projects for the clinical supply chain.

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EDUCATION, SKILLS AND EXPERIENCE REQUIRED:

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Bachelor's Degree in Chemistry or Pharmaceutical Chemistry with minimum of 15 years of drug development and clinical trial supply management.

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Must demonstrate excellent problem-solving skills and attention to detail; proven ability to understand and interpret data/information and its practical application, exceptional written and verbal communication skills and must be able to demonstrate outstanding scientific writing skills and ability to adapt style and content. Must have excellent technical editing and QC skills with reports, papers, proposals, etc., and efficiently discuss the same with other scientists, engineers, and customers.

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