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Expert Clinical Data Management(m/w/x)
Designing and implementing clinical trial data management processes, including EDC systems and eCRFs, for medical devices. Technical writing experience in medical/pharma and IVD/MD regulatory knowledge strongly preferred. Direct collaboration with project managers and statisticians.
Requirements
- Master's degree in life sciences or equivalent academic/vocational qualification
- Technical writer experience for medical/pharma company with high attention to detail
- Strongly preferred experience with IVD/MD regulatory landscape
- Preferred but not required experience with MD/IVD trials
- Preferred but not required experience in validation
- Effective verbal and written English communication
- Independent and reliable work managing multiple tasks/priorities in fast-paced international environment
Tasks
- Set up data management processes for clinical trials
- Create or select appropriate EDC systems
- Create or select non-EDC data transfer tools
- Create or review trial-specific eCRFs
- Collaborate with project managers and statisticians
- Support data cleaning and statistical evaluation
- Configure EDC databases
- Migrate EDC databases
- Test EDC databases
- Attend trial-specific team meetings
- Generate status reports and metrics
- Review clinical data
- Generate and close data queries
- Define data management process interfaces
- Train colleagues in clinical data management
Work Experience
- approx. 1 - 4 years
Education
- Vocational certification
Languages
- English – Business Fluent
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Expert Clinical Data Management(m/w/x)
Designing and implementing clinical trial data management processes, including EDC systems and eCRFs, for medical devices. Technical writing experience in medical/pharma and IVD/MD regulatory knowledge strongly preferred. Direct collaboration with project managers and statisticians.
Requirements
- Master's degree in life sciences or equivalent academic/vocational qualification
- Technical writer experience for medical/pharma company with high attention to detail
- Strongly preferred experience with IVD/MD regulatory landscape
- Preferred but not required experience with MD/IVD trials
- Preferred but not required experience in validation
- Effective verbal and written English communication
- Independent and reliable work managing multiple tasks/priorities in fast-paced international environment
Tasks
- Set up data management processes for clinical trials
- Create or select appropriate EDC systems
- Create or select non-EDC data transfer tools
- Create or review trial-specific eCRFs
- Collaborate with project managers and statisticians
- Support data cleaning and statistical evaluation
- Configure EDC databases
- Migrate EDC databases
- Test EDC databases
- Attend trial-specific team meetings
- Generate status reports and metrics
- Review clinical data
- Generate and close data queries
- Define data management process interfaces
- Train colleagues in clinical data management
Work Experience
- approx. 1 - 4 years
Education
- Vocational certification
Languages
- English – Business Fluent
About the Company
Greiner Bio-One GmbH
Industry
Healthcare
Description
Das Unternehmen Greiner Bio-One bietet einen Arbeitsplatz, an dem Team-Player und Visionäre in der Gesundheitsbranche Großes bewegen können.
Not a perfect match?
- Greiner AG
Expert Post Market Surveillance(m/w/x)
Full-timeOn-siteSeniorKremsmünsterfrom 59,781.96 / year - Greiner AG
Team Leader Post Market Surveillance(m/w/x)
Full-timeOn-siteSeniorKremsmünsterfrom 59,781.96 / year - Greiner Bio-One GmbH
Senior Expert Medical and Scientific Affairs(m/w/x)
Full-timeOn-siteSeniorKremsmünsterfrom 59,781.96 / year - Greiner AG
Global Product Manager(m/w/x)
Full-timeOn-siteExperiencedKremsmünsterfrom 59,781.96 / year - Greiner Bio-One GmbH
Biomedizinische:r Analytiker:in(m/w/x)
Full-timeOn-siteExperiencedKremsmünsterfrom 48,857 / year