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Project Manager - United States, Germany, India  

ECRON ACUNOVA (company)


Posted on : 10 April 2017

Project Description

Roles and Responsibilities Management of national and multinational clinical trials including Planning of clinical trials as regards contents, regulatory compliance and administrative and logistic aspects Interface management Management and co-ordination of CRAs: Coordination of national or multinational multicentre trials Supervision of GCP compliance Supervision of trial conduct, as regards monitoring, safety aspects, timelines, and trial budget Prospective and timely troubleshooting Continuous communication during the project with the sponsors and internally at EA Cooperation with data management, biometrics, medical writing, medical services and pharmacovigilance, quality assurance and other functions at EA or vendors Participating in and responding to in-house inspections and audits in collaboration with EA’s QA Department Requirements At least 3 years of experience in planning, conducting, supervising and evaluating clinical trials in accordance with GCP  preferably from another CRO.  Analytical mind-set and a strong talent for planning, organising and executing trial activities Excellent communication, organisational skills and team leading skills Ability to quickly understand medical issues within different therapeutics areas Good understanding of clinical research methodologies Very good command of written and spoken English. Command of other one or more European language will be an asset Understanding of regulatory procedures and guidelines in Europe Study of natural science (biology, medicine, pharmacy or nursing) or equivalent  e.g. Bachelor, Master or Ph.D. level Location Frankfurt

Locations

Princeton NJ 08540 USA 60528 Frankfurt Germany Whitefield Bangalore India

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