Set up of Data Management Processes for clinical trials for MDs and IVDs incl. creation and/or selection of an appropriate EDC system as well as non-EDC based data transfer tool Create and/or review of trial-specific (e) Case Report Forms (CRFs) according to clinical trial plan and clinical team input in a timely manner Work in close cooperation with the clinical project manager and statistician for efficient data cleaning and statistical evaluation on the course of the trial (spot checks), during interim analysis as well as trial closure Configure, migrate, and test electronic data capture (EDC) databases based on internal procedures, trial requirements, and system best practices Attend trial-specific team meetings and produce status reports and requested metrics, which may include query information or data trends Perform data review and query generation/closure Participate in the definition of interfaces between data management and existing processes and train colleagues in clinical data management as required Stellenbeschreibung: Your challenge
Set up of Data Management Processes for clinical trials for MDs and IVDs incl. creation and/or selection of an appropriate EDC system as well as non-EDC based data transfer tool Create and/or review of trial-specific (e) Case Report Forms (CRFs) according to clinical trial plan and clinical team input in a timely manner Work in close cooperation with the clinical project manager and statistician for efficient data cleaning and statistical evaluation on the course of the trial (spot checks), during interim analysis as well as trial closure Configure, migrate, and test electronic data capture (EDC) databases based on internal procedures, trial requirements, and system best practices Attend trial-specific team meetings and produce status reports and requested metrics, which may include query information or data trends Perform data review and query generation/closure Participate in the definition of interfaces between data management and existing processes and train colleagues in clinical data management as required Your profile
Master’s degree in a life sciences-related field or equivalent and relevant formal academic / vocational qualification. Experience as a technical writer or equivalent for a medical device or pharmaceutical company demonstrating high attention to detail Experience with regulatory landscape for IVDs and MDs is strongly preferred Experience with MD and/or IVD trials ispreferredbut not required Experience in validation preferred, but not required Effective and appropriate verbal and written communication in English with internal and external stakeholders, locally and globally Ability to work independently and reliably in managing multiple project tasks and prioritiesand in a fast-paced and changing international environment Our offer
We offer you an exciting and independent area of responsibility in a modern and collegial working environment. In addition to numerous attractive social benefits, the gross annual salary for this position is at least EUR 59.781,96(minimum salary according to the collective agreement for the chemical industry). Depending on your qualifications and professional experience, you may be eligible for a significant overpayment. If you have any questions or require further information about this job advertisement, please contact Manuela Silbermayr +43 664 8892 0539. Profilbeschreibung
Not applicable for interfaces
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Expert Clincial Data Management Arbeitgeber: Greiner
Als familiengeführtes Unternehmen in Pleidelsheim bieten wir eine inspirierende Arbeitsumgebung, die von Teamgeist und Innovation geprägt ist. Unsere Mitarbeiter profitieren von kurzen Entscheidungswegen, einem hohen Maß an Eigenverantwortung und der Möglichkeit, aktiv an der Weiterentwicklung unserer Qualitätsmanagementsysteme mitzuwirken. Wir fördern eine Kultur der kontinuierlichen Verbesserung und bieten zahlreiche Chancen zur persönlichen und beruflichen Weiterentwicklung in einem dynamischen Umfeld.
