About the job

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 60.977,70 (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!

Wir bieten gleiche Chancen für alle und sehen Vielfalt als unsere Stärke. Daher begrüßen wir Bewerbungen von allen Menschen – unabhängig von Merkmalen wie Geschlecht, Alter, Hintergrund, sozialem Status, sexueller Orientierung, Religion sowie geistigen und körperlichen Fähigkeiten. Es ist unser Ziel, Frauen im Unternehmen zu stärken und den Anteil an weiblichen Führungskräften zu erhöhen. Wir fördern eine inklusive Arbeitsumgebung und ermutigen alle Personen, sich zu bewerben.

Responsibilities

About the job

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

If you have any questions or require further information about this job advertisement, please contact Manuela Silbermayr +43 664 8892 0539.