Clinical Supply Chain Consulting needed to provide leadership in all aspects of clinical trial supply management and execution for small, CA based Phase 1/II immunology drug sponsor. The focus of this role will be to help coordinate clinical labeling and packaging, participate in IXRS vendor selection if necessary, IXRS set up and management for supply, and all inventory and order operations for the trial to ensure uninterrupted supply to patients. Consultant will need to be available to participate in all meetings as needed and will be an active member of the Study Management Team (SMT) ensuring that all deliverables provided are of the highest quality.
Project Scope:
| Project Start-up* | - Review and understanding of protocol design and timelines
- 1:1s with key stakeholders: Clinical Operations, Quality, Project Management, Study Management Team members, etc.
- Review and understanding of the clinical supply chain
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| Coordination of clinical labeling and packaging | - Provide input for kit and label design, as needed
- Help coordinate the packaging production runs, including batch records, etc.
- Should the trial expand outside of the US, help coordinate new labeling requirements, packaging runs (currently considering Canada and Australia as back-up options)
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| IXRS | - If needed, participate in the IXRS vendor selection representing supply needs
- Assist in the development of the IXRS specifications
- Perform UAT for the system set up
- Manage the IXRS system including inventory load, site parameters, temp excursions, etc.
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| SMT Support and Participation | - Provide input in the development of supply related study documents including protocol, pharmacy manuals, training materials, etc.
- Attend the meeting representing clinical supply chain, including progress on inventory, projections, etc.
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| Inventory Management | - Monitor inventory to ensure sufficient supply at all stages of the study for a total of 10 SKUs (5 active and 5 placebo)
- Provide inventory reports and projections as needed
- Expiry management and or relabeling (as needed)
- Manage returns and destruction
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| eTMF and Study Close Out | - Own the supply portion of the eTMF and any required close out activities for documentation, inventory, etc.
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| Ad Hoc activities | - During the course of a clinical trial it may become necessary to provide unplanned support. Patrick Milliken will be available at all times to provide such support and will ensure that there are no delays based upon need for clinical supplies for the trial.
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*All activities refer to the phase I-II study being designed at the current time
Timelines
Expectation is .25% FTE for one year, with the option to extend.
