Greiner Bio-One GmbH
Expert Clinical Data Management(m/w/x)
Full-timeWith HomeofficeExperienced
from 59,781.96 / year
Kremsmünster
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GRGreiner Bio-One GmbH
Clinical Monitoring(m/w/x)
Kremsmünster
from 59,781.96 / year
Full-timeWith Home OfficeExperienced
Nejo AI Summary
You will drive the success of clinical trials by managing site monitoring and regulatory compliance, ensuring data integrity while acting as the vital link between trial sites and the sponsor.
Requirements
- Degree in biology, medicine, pharmacy or equivalent
- Two years experience as clinical monitor
- Knowledge of ICH-GCP, ISO 14155, ISO 20916
- Knowledge of MDR, IVDR and GDPR
- Advantageous experience of FDA, ISO, CLSI
- Independent and reliable work style
- Excellent German and English communication skills
- Willingness to travel
Tasks
- Collaborate with clinical project teams to set objectives and timelines
- Conduct IVD and MD studies following protocols and regulations
- Perform feasibility assessments for trial sites
- Execute site initiations and on-site monitoring visits
- Monitor GBO labs and conduct remote monitoring sessions
- Manage trial site close-out visits
- Train study team members on protocol and local regulations
- Ensure the accuracy and completeness of study data
- Support international trial submissions to authorities and ethics committees
- Act as the primary liaison between trial sites and sponsors
- Create study-specific forms
- Maintain the Trial Master File
Work Experience
2 years
Education
Bachelor's degree
Languages
German – Business FluentEnglish – Business Fluent
Tools & Technologies
ICH-GCPISO 14155ISO 20916MDRIVDRGDPRFDA regulationsISO regulationsCLSI guidelines
Benefits
Flexible Working
- •Remote work
Informal Culture
- •Inclusive work environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Greiner Bio-One GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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GRGreiner Bio-One GmbH
Clinical Monitoring(m/w/x)
Kremsmünster
from 59,781.96 / year
Full-timeWith Home OfficeExperienced
Nejo AI Summary
You will drive the success of clinical trials by managing site monitoring and regulatory compliance, ensuring data integrity while acting as the vital link between trial sites and the sponsor.
Requirements
- Degree in biology, medicine, pharmacy or equivalent
- Two years experience as clinical monitor
- Knowledge of ICH-GCP, ISO 14155, ISO 20916
- Knowledge of MDR, IVDR and GDPR
- Advantageous experience of FDA, ISO, CLSI
- Independent and reliable work style
- Excellent German and English communication skills
- Willingness to travel
Tasks
- Collaborate with clinical project teams to set objectives and timelines
- Conduct IVD and MD studies following protocols and regulations
- Perform feasibility assessments for trial sites
- Execute site initiations and on-site monitoring visits
- Monitor GBO labs and conduct remote monitoring sessions
- Manage trial site close-out visits
- Train study team members on protocol and local regulations
- Ensure the accuracy and completeness of study data
- Support international trial submissions to authorities and ethics committees
- Act as the primary liaison between trial sites and sponsors
- Create study-specific forms
- Maintain the Trial Master File
Work Experience
2 years
Education
Bachelor's degree
Languages
German – Business FluentEnglish – Business Fluent
Tools & Technologies
ICH-GCPISO 14155ISO 20916MDRIVDRGDPRFDA regulationsISO regulationsCLSI guidelines
Benefits
Flexible Working
- •Remote work
Informal Culture
- •Inclusive work environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Greiner Bio-One GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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.
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