Expert Clinical Data Management (all genders)

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 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.

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