Clinical Data Manager (m/w/d)

Job title:

Clinical Data Manager (m/w/d)

Company

Greiner

Job description

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 is preferred but 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 priorities and in a fast-paced and changing international environment

Our OfferWe offer you an exciting and independent area of responsibility in a modern and collegial working environment. Due to legal requirements in Austria, we are obligated to disclose the minimum gross salary for the position as defined by the collective agreement which amounts to EUR 58.200,00 (collective agreement for the chemical industry). Depending on your qualifications and professional experience, you may be eligible for a significant overpayment.Wir stehen als Arbeitgeber für Chancengleichheit und berücksichtigen alle qualifizierten Bewerber:innen unabhängig von Merkmalen wie Geschlecht, Alter, Hintergrund, sozialem Status, sexueller Orientierung, Religion sowie geistigen und körperlichen Fähigkeiten. Wir haben uns das Ziel gesetzt, den Frauenanteil in Führungs- und Expertenfunktionen zu erhöhen und ermutigen daher qualifizierte Frauen sich zu bewerben.Job ID: 2519Über Greiner Bio-OneGreiner Bio-One ist ein Zuhause.Für Visionäre, die sich mit Power und Ideen einbringen, für Team-Player, die Wissen teilen und neue Denkweisen zulassen, für Menschen, die nach Exzellenz streben. Greiner Bio-One hat offene Türen für Könner, Macher und verborgene Talente, die in der Gesundheit Großes bewegen wollen.Wir haben Zukunft im Blut!

Expected salary

Location

Kremsmünster, Oberösterreich

Job date

Fri, 14 Feb 2025 06:40:32 GMT

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