CTS Study Manager (f/m) CSL Behring GmbH Marburg Planning, implementation and management of the logistics network for international clinical studies requiring a complex supply concept and in close collaboration with internal global specialty departments and external service providers;... is one of the world's leading manufacturers and providers of innovative life-saving pharmaceuticals made from human plasma as well as related treatments the company has approximately 12000 employees globally of which there are about 2300 in germany at the largest production and research location of in marburg people who work for are committed to saving the lives of patients throughout the world this involves top performance as we strive to be the best join our team in the global logistics department as a cts study manager (f/m) main responsibilities and accountabilities planning implementation and management of the logistics network for international clinical studies requiring a complex supply concept and in close collaboration with internal global specialty departments and external service providers planning and implementation of the packaging design in compliance with country regulations and study specific requirements development and maintenance of clinical supply material demand plans and adaptation to study specific needs identification of quality standards and product specifications for all clinical supply materials determination of product demands and coordination of the supply with the production departments at all manufacturing sites sourcing of all non clinical supply materials development and maintenance of the logistics and product budget for clinical studies coordination of a timely high quality and on demand packaging and supply of all medicinal products and ancillary supplies leading clinical supply meetings generation or review of study documents relevant for regulatory submission preparation and conduct of trainings and presentations on international investigator meetings generation of documents for study sites enabling a gcp and gmp compliant documentation of handling and usage of the study medication as well as the regular review of the completed documentation training of external study monitors and internal global study teams in regards to study specific supply chain processes generation of final drug reconciliation reports for the entire clinical study visiting study sites to discuss options for the optimization of the study specific imp supply and imp documentation generation of study specific request for proposals and review of the quotes management of clinical manufacturing organizations (cmo) and leading meetings with them processing of deviations reported from external service providers in compliance with company standards and existing quality agreements review of study specific software specifications (irt) maintenance of data in irt systems and provision of status reports generation and monitoring of the study specific logistics and product budget generation of study specific cost reports preparation of inspections / audits regarding imp supply related topics and participation as imp supply representative from the sponsor site timely processing and completion of audit and inspection findings generation of sops and other quality related documents qualifications bachelor's degree in life science logistics or project management required professional experience: at least 4-5 years' relevant experience in clinical supply management or r&d project management excellent written and oral communication skills in german and english required what you need to know your basic salary is based on the attractive collective agreement of the chemical industry in addition to this we offer you discretional benefits such as bonuses profit shares and an outstanding company pension scheme we also support you with flexible working hours and family-friendly options such as places in a kindergarten and childcare during the school holidays interested then we are looking forward to receiving your comprehensive online-application http://marburgde master bachelor of science logistik projektmanagement projektmanager klinische studien klinische forschung logistics project management projectmanagement organisation manager cts clinical supply CTS Study Manager (f/m) Planning implementation and management of the logistics network for international clinical studies requiring a complex supply concept and in close collaboration with internal global specialty departments and external service providers Marburg



Die Stellenanzeige CTS Study Manager (f/m) von CSL Behring GmbH wurde zuletzt aktualisiert am 15.03.2016.



ähnliche Jobs und Stellenangebote:

» Jobs im Berufsfeld Ingenieurberufe / Techniker
» Jobs in Marburg