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 tri…
Skills: Clinical data management, EDC system configuration, Data cleaning, Statistical evaluation, Case report forms
Specialist IT Business Applications People & Culture (all genders)
Kremsmünster, Upper Austria, Austria · On-site
Mid level
Join #TeamGreiner! Are you passionate about HR and IT? Do you thrive in dynamic environments and love solving complex problems? If so, we have the perfect opportunity for you to join our innovative team! Your challenge Y…
Skills: SAP SuccessFactors, SmartRecruiters, HR systems, Application consulting, 2nd-level support
Specialist IT Business Applications People & Culture (all genders)
Kremsmünster, Upper Austria, Austria · On-site
Mid level
Join #TeamGreiner! Are you passionate about HR and IT? Do you thrive in dynamic environments and love solving complex problems? If so, we have the perfect opportunity for you to join our innovative team! Your challenge Y…
Skills: SAP SuccessFactors, SmartRecruiters, HR Systems, Application Consulting, Project Management
Prozessspezialist Produktion im Produktionsmanagement (m/w/d) - Teilzeit
Frickenhausen, Baden-Württemberg, Germany · On-site
Mid level
Aufgaben Du hast Freude daran, Abläufe zu verbessern, Prozesse verständlich zu machen und gemeinsam mit der Produktion nachhaltige Lösungen umzusetzen? Dann gestalte mit uns die Weiterentwicklung unserer produktionsnahen…
Skills: Lean Management, Six Sigma, Continuous Improvement, Process Optimization, Production Management
Dieses Aufgabenspektrum bieten wir: Als Senior Expert im Global Controlling arbeiten Sie in der Rolle als Senior Business Partner eng mit dem globalen und lokalen Top-Management sowie den Verantwortlichen der Business Un…
Skills: Global Controlling, Business Partnering, Performance Management, Financial Planning, Budgeting
Your Challenge Conceptualization, research, creation and coordination of product-related master content for various communication materials, ensuring alignment with the global marketing strategy, go-to-market plan, launc…
Mitarbeiter:in Qualitätskontrolle im 3-Schichtbetrieb
Kremsmünster, Upper Austria, Austria · On-site
$3k/mo
Entry level
Dieses Aufgabenspektrum bieten wir Durchführung von Qualitätsprüfungen im 3-Schichtbetrieb Ausführung visueller Prüfungen zur Sicherstellung der Produktqualität Umsetzung maßlicher Prüfungen nach vorgegebenen Spezifikati…
Dieses Aufgabenspektrum bieten wir: Recruitingprozess (Briefing, Suchstrategie, Erstellung der Anzeigen, Auswahlprozess....) Ausarbeitung und Umsetzung von Gesundheitsmaßnahmen Betreuung der Präventivkräfte Konzeption un…
Skills: Recruiting, Employer Branding, Onboarding, Exit Management, Health Management
Technik ist genau dein Ding und du packst gerne selbst an? Dann bring dein Know-how bei uns ein und halte unsere Produktion am Laufen. Deine Aufgaben Instandhaltung, Wartung und Reparatur von Maschinen und Produktionsanl…
Responsibility: Prepare chemical additives for production Complete QC testing for prepared chemical additives Perform IGI and release chemicals for use. Cleaning and sanitation of laboratory / QC areas Release of solutio…
Skills: Chemical Preparation, Quality Control Testing, SAP, Inventory Management, Documentation
Head of Integrated Management System (all genders)
Kremsmünster, Upper Austria, Austria · On-site
Senior+
Ihre Herausforderung Leitung und Weiterentwicklung der Abteilung "Integrierte Management Systeme" und dem engagierten Team mit 15 Mitarbeiter:innen Strategische und operative Verantwortung für Qualitätsmanagement, Arbeit…
Skills: Integrated Management Systems, Quality Management, Occupational Health and Safety, Environmental Management, Energy Management
Your challenge Partners with department leadership (managers/supervisors) to coach and guide towards the appropriate organizational development. Ability to align HR strategy to business strategy. Acts as change agent to …
Skills: Human Resources, Strategic Planning, Employee Relations, HRIS, Payroll Systems
Ihre Herausforderung Eigenständige Erstellung, Prüfung und Verhandlung von kommerziellen Verträgen (insbesondere Sales und Einkauf) in einem internationalen Umfeld Unterstützung der Business Units bei einem hohen Vertrag…
Skills: Contract Law, Commercial Contract Negotiation, AI Implementation, Intellectual Property Law, Legal Process Standardization
Ihre Herausforderung Eigenständige Erstellung, Prüfung und Verhandlung von kommerziellen Verträgen (insbesondere Sales und Einkauf) in einem internationalen Umfeld Unterstützung der Business Units bei einem hohen Vertrag…
Skills: Commercial Contract Law, Contract Negotiation, AI Implementation, Intellectual Property Law, Legal Process Standardization
Ihre Herausforderung Eigenständige Erstellung, Prüfung und Verhandlung von kommerziellen Verträgen (insbesondere Sales und Einkauf) in einem internationalen Umfeld Unterstützung der Business Units bei einem hohen Vertrag…
Join #TeamGreiner! Do you stay organized and focused even when managing multiple tasks at the same time? As a Team Assistant Commercial (all genders), you will be an important administrative and organizational interface …
Join #TeamGreiner! Sie behalten auch dann den Überblick, wenn viele Aufgaben gleichzeitig anfallen? Als Team Assistant Commercial (all genders) sind Sie eine wichtige organisatorische und administrative Schnittstelle inn…
Twoje wyzwanie Wspieranie użytkowników końcowych SAP FI/CO – rozwiązywanie bieżących problemów i udzielanie konsultacji dotyczących modułu finansowego (FI). Monitorowanie poprawności działania systemu SAP FI/CO – identyf…
Skills: SAP FI, SAP CO, Financial Accounting, Controlling, Process Optimization
Dieses Aufgabenspektrum bieten wir Führung, Einsatzplanung und Koordination des Intralogistik-Teams im Schichtbetrieb Sicherstellung eines reibungslosen Materialflusses sowie Steuerung des operativen Tagesgeschäfts Absti…
Skills: Team Leadership, Deployment Planning, Intralogistics Coordination, Material Flow Management, SAP
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Full-time
postgraduate degree
Social benefits
Posted 14d ago
~40 hrs/week
Responsibilities
The role involves setting up data management processes for clinical trials, including EDC system configuration and the creation of case report forms. You will collaborate with project managers and statisticians to ensure efficient data cleaning, statistical evaluation, and accurate status reporting.
Requirements
Candidates must hold a Master’s degree in a life sciences-related field and possess experience in technical writing for medical device or pharmaceutical companies. Strong knowledge of the regulatory landscape for IVDs and MDs is preferred, along with excellent communication skills in English.
Full 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 and German 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 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 60.977,60 (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.
If you are passionate about promoting innovative medical devices and possess the skills and experience outlined above, we encourage you to apply for this exciting opportunity to join our dynamic team at GBO. Please submit your resume and cover letter detailing your relevant experience and qualifications. We look forward to hearing from you!
Greiner Bio-One specializes in the development, production and distribution of high-quality plastic laboratory products. The company is a technology partner for hospitals, laboratories, universities, research institutes, and the diagnostic, pharmaceutical and biotechnology industries. Greiner Bio-One has specialized in two business division, Preanalytics and BioScience.
The Preanalytics business division, with headquarters in Kremsmünster (Austria), develops and produces innovative collection systems for human and veterinary blood, urine and saliva samples, with the aim of making day-to-day, routine tasks in hospitals, laboratories and doctors’ practices easier and safer. This division also covers customized software solutions (Greiner eHealth Technologies) which ensure greater efficiency and patient safety in the preanalytical process.
Greiner Bio-One’s BioScience division, with headquarters in Frickenhausen (Germany), is one of the leading providers of specialist products for the cultivation and analysis of cell and tissue cultures. Based on decades of experience in the cryopreservation of samples, Greiner Bio-One also offers solutions for automated storage systems in biobanks. In addition, the division also develops and produces microplates for high-throughput screening, which ensure the quickest and most efficient testing of substances and materials in both industry and research.
Greiner Bio-One (then Greiner Labortechnik) was founded in 1963 in Nürtingen (Germany) and started with the manufacture of the first plastic Petri dishes. Today, Greiner Bio-One International GmbH is located in 28 locations in 22 countries. The company employs 2,540 people and is part of Greiner AG, headquartered in Kremsmünster (Austria).
We welcome you to the Greiner Bio-One Americas page, which not only shares global company news but also highlights updates from our subsidiaries in North and South America.
Offices: 4328 Capital Drive, Monroe, North Carolina 28110, US · Bad Haller Straße 32, A-4550, Kremsmünster, AT · Avenida Afonso Pansan, 1967 – Vila Bertini, Americana, São Paulo 13473-620, BR
Greiner Bio-One specializes in the development, production and distribution of high-quality plastic laboratory products. The company is a technology partner for hospitals, laboratories, universities, research institutes, and the diagnostic, pharmaceutical and biotechnology industries. Greiner Bio-One has specialized in two business division, Preanalytics and BioScience.
The Preanalytics business division, with headquarters in Kremsmünster (Austria), develops and produces innovative collection systems for human and veterinary blood, urine and saliva samples, with the aim of making day-to-day, routine tasks in hospitals, laboratories and doctors’ practices easier and safer. This division also covers customized software solutions (Greiner eHealth Technologies) which ensure greater efficiency and patient safety in the preanalytical process.
Greiner Bio-One’s BioScience division, with headquarters in Frickenhausen (Germany), is one of the leading providers of specialist products for the cultivation and analysis of cell and tissue cultures. Based on decades of experience in the cryopreservation of samples, Greiner Bio-One also offers solutions for automated storage systems in biobanks. In addition, the division also develops and produces microplates for high-throughput screening, which ensure the quickest and most efficient testing of substances and materials in both industry and research.
Greiner Bio-One (then Greiner Labortechnik) was founded in 1963 in Nürtingen (Germany) and started with the manufacture of the first plastic Petri dishes. Today, Greiner Bio-One International GmbH is located in 28 locations in 22 countries. The company employs 2,540 people and is part of Greiner AG, headquartered in Kremsmünster (Austria).
We welcome you to the Greiner Bio-One Americas page, which not only shares global company news but also highlights updates from our subsidiaries in North and South America.
Offices: 4328 Capital Drive, Monroe, North Carolina 28110, US · Bad Haller Straße 32, A-4550, Kremsmünster, AT · Avenida Afonso Pansan, 1967 – Vila Bertini, Americana, São Paulo 13473-620, BR