Expert Clincial Data Management

Greiner; Schürzendorf; Vor Ort; EUR 54.000 - 66.000; Vollzeit

Benefits dieser Stelle

Attraktive Sozialleistungen

Zusammenfassung

Greiner sucht eine Fachkraft im Bereich Datenmanagement für klinische Studien. Sie richten Datenmanagementprozesse ein, wählen oder erstellen EDC-Systeme und unterstützen den Datentransfer außerhalb von EDC.

Sie erstellen CRFs, arbeiten eng mit dem klinischen Projektleiter und dem Statistiker zusammen, testen Systeme und berichten Status/ Kennzahlen, sowie Schulungen für das Team im Datenmanagement.

Qualifikationen

• Master’s degree in a life sciences-related field or equivalent und relevante formale akademische/vocational Qualifikation.
• Erfahrung als technischer Redakteur oder vergleichbar für ein Medizinprodukt oder Pharmaunternehmen mit großer Detailgenauigkeit.
• Erfahrung mit regulatorischen Vorgaben für IVDs und MDs ist wünschenswert.
• Erfahrung mit MD- und/oder IVD-Studien ist bevorzugt, aber nicht zwingend.
• Effektive mündliche und schriftliche Englisch-Kommunikation mit internen und externen Stakeholdern, lokal und global.
• Fähigkeit, eigenständig zu arbeiten und mehrere Projekte priorisiert in einem schnelllebigen, internationalen Umfeld zu managen.

Aufgaben

• Datenmanagementprozesse für klinische Studien einrichten und EDC-/nicht-EDC-Datenübertragungen implementieren.
• CRFs gemäß Studienplan und Teamvorgaben erstellen bzw. prüfen.
• Mit dem klinischen Projektmanager und dem Statistiker für Datenbereinigung und statistische Auswertung zusammenarbeiten.
• EDC-Datenbanken gemäß internen Verfahren testen, migrieren und konfigurieren.
• Teilnahme an projektbezogenen Teammeetings, Erstellung von Statusberichten und Kennzahlen.
• Datenüberprüfung und Generierung/Schließung von Queries.
• Mitwirkung an Schnittstellen zwischen Data Management und bestehenden Prozessen; Schulung von Kolleginnen/Kollegen.

Kenntnisse

Life sciences knowledge

Technical writing

Regulatory experience

English communication

Project management

Ausbildung

Master’s degree in life sciences or equivalent

Formal academic/vocational qualification

Jobbeschreibung

• 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 [phone].

Profilbeschreibung

Not applicable for interfaces