Quality - Trial Supplies Manager - Lawrenceville

Only for registered members Lawrenceville, United States

2 weeks ago

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Job summary

This position is responsible for the supply planning and inventory management of clinical supplies required to support global clinical research and development studies during phases 1-4. Collaborating with internal and external Customers and Service Providers including but not limited to Clinical Research and Development Global Study Management and Monitoring GSMM Project Management Client Affiliates Medical Affairs MA Regulatory CMC QA Packaging Vendors CROs IRT Organizations Global Clinical Supply Chain Functional Operations to ensure all needs are met.

Responsibilities

The individual must partner closely with clinical regulatory quality production associates to ensure timely delivery of supplies to study participants working with teams for optimal use of the investigational material supply chain to achieve study corporate goals identifying supporting strategies for continuous improvement departmental interdepartmental projects co creating clinical development timelines directly responsible communicating timelines investigational product strategies Study Teams crossfunctional teams proactively defining planning communicating clinical supply strategy support global clinical studies monitoring reacting unforeseen changes developing supply forecasts evaluation clinical development plan protocol analysis reviewing providing draft medical protocols develop packaging labelling configurations create packaging specifications collaboration Clinical Operations partners collaborating Global Clinical Supply Chain functions vendors package design label development investigational product meet protocol regulatory requirements monitoring longterm inventory allocation strategies drug recertification country specific regulatory requirements international drug shipment overall demand performing analytical assessments drug utilization current forecasts inventories creating product orders needed working thirdparty vendors timely efficient highquality costeffective execution outsourced activities ensuring releasable supplies assigned compounds Protocols considering country Regulatory QP Release documentation requirements initiating reviewing approving IRT specifications participating user acceptance testing developing investigational product distribution strategies maintaining distribution supply strategy depot site level according study IRT requirements actively Trial Supplies Management Functional team Study Team Country Medical Affairs Affiliate CSC Matrix Team Meetings providing relevant data documentation risks mitigation required actively supports budget process acting main contact person Compound associated studies lead communications regarding global supply strategy necessary identified strategic operational issues develop proposals outlining solutions managing conflicts issues internal external partners customers demonstrating knowledge presenting processes crossfunctional meetings participates coaching new Trial Supply Managers tasks training efforts functions improved relationships speaking Investigator Meetings traveling input SOPs performs other tasks assigned.
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