Clinical Supply Specialist (Bucharest, Romania)
Parexel International Corporation
Bucharest, București, Romania
The Clinical Supply Specialist (CSS) will support the Clinical Supply Leader with the development and applying the study specific supply chain strategy incl. the sourcing and distribution strategy and the technical management for Clinical Trial Supply and Logistics projects. The CSS supports the Clinical Trial Supply and Logistics teams by applying and executing supply chain to achieve client satisfaction and delivery of projects /programs on time, to budget, to the highest quality and in compliance with ICH GCP and GxP. The CSS has responsibility for the execution of the clinical trial supply logistics strategy on the project.
* Engaging with Clinical Supply Leader to develop logistics concepts and solutions in order to meet the client’s satisfaction and meeting the profitability of the projects
* Keeping up to date with study scope and progress to ensure that study/project timelines and budgets are met in accordance to the contractual agreement including proactive management and communication of any changes and/or risks.
* Ensure that study specific management tools and documents are in place
* Management of own resources assigned to the project to ensure the CTSL FTE assigned is appropriate and meeting the study’s requirement
* Pass Thru Cost (PTC) management with controls and reporting of costs for internal service fees and external providers.
* Collaborate with team to develop a clinical supply, sourcing and distribution strategy with relevant stakeholder and make sure that required documentation is in place
* Communicate with 3rd party providers and negotiate scope of work in conjunction with procurement.
* Develop and plan inventory according to strategy, quantities, and forecast
* Work with depots.QualificationsClient focused approach to work.
Ability to manage multiple and varied tasks with attention to details.
Self- Motivated with a professional attitude.
Capacity to work effectively in a matrix environment and value the importance of teamwork.
Basic Project management skills.
Proficient use of MS office suite.
Excellent interpersonal, verbal and written communication skills.
Good understanding of the GxP regulatory framework desired.
Educated to B.A/ B.S. or Master degree, or equivalent (e.g. Pharm. D.), in biology, pharmacy, or other health – related discipline, international trade, logistics or relevant work experience.