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Trial Supply Manager
Onsite in Bridgewater, NJ
8 - 24 Month Contract
-Bachelor of Science degree (BS) in Health Science or related discipline
-at least 5 years' experience in pharmaceutical business required.
-The individual must be well versed in all aspects of the clinical supply chain process, GMP, GDP and other regulatory requirements as they pertain to investigational products.
-Excellent knowledge of business units, scientific core platforms and interfaces.
-Clinical study protocols and IP related activities with particular emphasis on the manufacturing/packaging, global distribution and strategy.
-Thorough understanding of GMP & GDP (IP production and distribution).
-Thorough understanding of IRT systems.
-Good understanding of CMC and clinical study conduct activities Excellent oral and written communication skills high attention to detail.
-Excellent negotiation skills, strong problem solving skills.
-Excellent ability to multitask and prioritize workload within a dynamic, culturally diverse organization; effective time management skills.
-Exercises calm, sound constructive judgment during highly demanding situations.
-Ability to organize and lead meetings.
-Experience with MS Office Suite (Excel, Word, PowerPoint) required.
As the Trial Supply Operations Manager (TSOM), the candidate will interpret the clinical study protocol and determine study IMP / NIMP / ancillary needs. The TSOM will then coordinate the procurement, manufacture, packaging and labeling of the supplies for both the initial campaign and any resupplies that are needed. Furthermore, the TSOM will manage the distribution logistics for assigned projects throughout the planning, execution, and close out of Phase I - IV clinical studies to ensure the objectives of the studies are met.
Forecasting IMP/NIMP/ancillary needs based on protocol design.
Manage the distribution logistics for assigned projects.
Develop and apply the distribution strategy (for IRT and non-IRT studies) that ensures continuity of IP at depots and investigational sites.
Develop IRT specifications and perform UAT, prior to IRT Go Live
Ensure all critical parameters are considered for every distribution strategy; IRT specifications (e.g. initial or resupply quantities); any QP release, study, expiry, customs, import/export, brokerage or country specific requirements.
Work with relevant departments to create master labels for each study.
Ensure adequate stock at depot and site levels.
Support relabeling activity at local and depot levels.
Support transfers of supplies between sites and/or depots.
Generate and/or review shipment requests for accuracy & completeness prior to issuance.
Ensure accuracy of IP receipt for all shipments and availability in IRT for applicable studies.
Ensure final drug reconciliation is completed.
Provide adequate communication and documentation relevant to the clinical study plan and the movement of all investigational products.
Contribute to the budgeting and forecasting for all clinical studies.
Offer creative solutions/proposals to optimize the clinical supply chain.
Attend various project team meetings.
Conduct Operational Supply Meeting
Work with Clinical Trial Team to ensure that forecasting projections and manufacturing schedules are in line with trial progress.
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