Clinical Research Manager Nr ref.: /JOBS.pl CLINICAL RESEARCH ASSOCIATE (TMF) (M/F)Standort IngelheimThere is an excellent job opportunity opening up working for one of our well-known clients in Ingelheim, offered as at least 12 months project . Here is an in-depth job description.Your responsibilitiesThe CRA will be involved in most activities like in preparation for study set up, conduct and completing a Clinical Trial which usually includes:Manage documentation associated with clinical trials, both in paper and electronic format, including transitions and conversions.Follow records management tasks, policies and procedures protecting record integrity by ensuring full compliance to GCP principles and client SOPs.Perform audit and quality control checks on paper based studies and Electronic Data Capture systems.Experience in using electronic document management system (First Doc - Documentum), including QC approval of workflows and uploadingReceive, process and track all clinical project related paper and electronic documents including global study and site documentsCreate and maintain filing structure for all the regulatory INDs, NDAs, CTAs, DMFs and SBAsFulfill company-wide requests for documents, records, and study reports; Liaise with study teams to coordinate the flow of trial documentation to the Records CenterSupport project teams and functions in the preparatory activities for sponsor audits and regulatory inspections.Conduct and manage electronic Trial Master File (eTMF) processes and train staff and deliver presentations regarding eTMF policies and procedures to disseminate knowledge and increase compliance.Maintain logs and indexes to ensure information status is audit ready at all times and assist in the collection of dataManage and oversee the external archiving providers, including tracking of documents between Client and the external archiveYour profileUniversity degree or equivalent in health sciences, nursing or pharmacy or related fieldPrevious experience of working in Clinical Research or the Pharmaceutical IndustryKnowledge of the Industry/Clinical trial process and drug developmentKnowledge of ICH GCP and Trial Master FileUnderstand clinical trial processes and needsExcellent organizational skills and time managementGood attention to detailWork under pressure and to deadlinesPro- active, flexible and able to multi-taskSelf motivationWork in a team and independentlyExcellent communication and influencing skillsIT literacy, particularly in Word, Excel and PowerPointGerman language would be an advantageIn 2015, we were awarded the title of one of "Germany's top employers" for the tenth time. That's the fourth time in a row on the podium. Benefit from our expertise and get to know one of the most successful HR service contractors in Germany! Find out more about us at ContactFrau Kathrin AGLife ScienceAdenauerallee OberurselPhone / Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .
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