Clinical Supply Operations Manager in The Fountain Group

Details:Job Title: Manager, Clinical Supply OperationsJob Location: EST/CST remote is acceptable for strong candidates, NJ is preferred (not required). Pay for this position is 82.00 to 89.29 hourly depending on experience.This position is a one year contract with the possibility of extension or conversion to permanent. Requirements:Minimum 5 years of related experienceExperience in Project Management, Clinical Supply Management, and/or Pharmaceutical Development requiredExperience and skill in the processes for assimilation and destruction or returned drug supply as well as experience managing third-party contract clinical supply operations requiredGlobal experience required (member of a team)Good knowledge of cGMPs and GCPs across multiple therapeutic areas and possesses general knowledge of blinding approaches and technologies to support various clinical trial designs (randomized, double-blind, double-dummy, placebo-controlled, cross-over, etc.)Experienced to manage study needs and possesses the skills and ability to potentially support large phase III Programs. Such characteristics include the ability to evaluate, at times, limited information, to create packaging designs and accurate drug supply forecast. Experienced in managing third-party contract clinical supply operations. Support the CSO strategy on specific Programs and Projects to support corporate goals and objectives.Employee should have comprehensive knowledge of IRT design for control of drug dispensing and inventory management. Knowledge of Import/export regulations, including pro-forma invoice generation, import regulations at a Global level, regulations for IMP QP requirements.DescriptionParticipate in study team meeting, align with study details, and collaborate in meeting study objective, Provide supporting information to the teams, in particular RA, RACMC, Clinical ops, and GPMs.Design packaging requirements; based on a general understanding of the technical aspects of packaging in order to evaluate patient kit design and potential solutions to provide patient friendly designs and support of simplified site dispensing approaches.Create drug supply forecast for packaging and labeling operations. Support patient study needs that consider enrollment rates, country logistics for shipping and importation, drug expiry, inventory re-supply strategy and the appropriate level of inventory per region.On-going monitoring of recruitment, drop-out rates and actual supply needs, critical to managing the study needs. Ensure continuous re-assessment of Project needs as recruitment and the study progressesSourcing of comparators and matching placebo as required on a Project by Project basis.Drive label generation and approvals, including obtaining translations for all participating countries and the associated regulatory statements. Obtaining cross functional sign off on the labels.ability to provide budget management for Projects - initial budgets are prepared against available information and a set of assumptions and become more stringent as the study start approaches. Spend against PO's are monitored and extensions justified. Costs saving strategies are employed when appropriate. Invoices are reviewed and approved against targeted budget plans.Generate RFPs for Vendor Proposals - Breakdown Protocols into component parts to support the supply strategy and communicate the study needs to obtain vendor based budgeting or internal support.Vendor selection to support studies is evaluated according to capability and fit with outsourcing Strategy and selection of contractors is made in agreement with line management. Show more Show less Должностной уровень Руководитель среднего звена Тип занятости Договор Должностные обязанности Научная деятельность Отрасли Фармацевтическое производство