BeOne Medicines Germany GmbH
Senior Clinical Research Associate(m/w/x)
Full-timeRemoteSenior
Hamburg, Bremen, Berlin
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BEBeOne Medicines Germany GmbH
Clinical Research Associate(m/w/x)
Hamburg, Bremen, Berlin
Full-timeRemoteExperienced
Nejo AI Summary
Overseeing oncology and hematology trials at a patient advocacy organization. Minimum 2 years monitoring experience required, oncology global trials experience preferred. Regular travel to trial sites.
Requirements
- BS in relevant scientific discipline
- Minimum 2 years monitoring experience
- Experience in oncology global trials preferred
- Understanding of clinical trial processes
- Knowledge of ICH and regulatory guidelines
- 2 years pharmaceutical/CRO monitoring experience
- Experience in oncology/hematology trials preferred
- Excellent communication and interpersonal skills
- Excellent organizational and multi-tasking skills
- Fluency in English and German
- Efficiency in Microsoft Office and Outlook
Tasks
- Execute clinical monitoring at trial sites
- Adhere to ICH guidelines and GCP standards
- Perform site selection and initiation activities
- Monitor oncology and hematology clinical trials
- Collaborate with the Regional Clinical Operations Manager
- Maintain study timelines and quality standards
- Identify gaps and propose corrective actions
- Support study start-up with local expertise
- Conduct site identification and feasibility assessments
- Provide protocol training to assigned sites
- Perform routine monitoring and closeout visits
- Complete detailed monitoring visit reports
- Track regulatory submissions and recruitment progress
- Manage CRF completion and data query resolution
- Maintain regular communication with clinical sites
- Ensure inspection readiness for all studies
- Facilitate site audits and oversight visits
- Escalate quality and GCP issues appropriately
- Attend disease-specific and general CRA training
Work Experience
- 2 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- Microsoft Word
- Excel
- MS Project
- MS PowerPoint
- Outlook
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BeOne Medicines Germany 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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BEBeOne Medicines Germany GmbH
Clinical Research Associate(m/w/x)
Hamburg, Bremen, Berlin
Full-timeRemoteExperienced
Nejo AI Summary
Overseeing oncology and hematology trials at a patient advocacy organization. Minimum 2 years monitoring experience required, oncology global trials experience preferred. Regular travel to trial sites.
Requirements
- BS in relevant scientific discipline
- Minimum 2 years monitoring experience
- Experience in oncology global trials preferred
- Understanding of clinical trial processes
- Knowledge of ICH and regulatory guidelines
- 2 years pharmaceutical/CRO monitoring experience
- Experience in oncology/hematology trials preferred
- Excellent communication and interpersonal skills
- Excellent organizational and multi-tasking skills
- Fluency in English and German
- Efficiency in Microsoft Office and Outlook
Tasks
- Execute clinical monitoring at trial sites
- Adhere to ICH guidelines and GCP standards
- Perform site selection and initiation activities
- Monitor oncology and hematology clinical trials
- Collaborate with the Regional Clinical Operations Manager
- Maintain study timelines and quality standards
- Identify gaps and propose corrective actions
- Support study start-up with local expertise
- Conduct site identification and feasibility assessments
- Provide protocol training to assigned sites
- Perform routine monitoring and closeout visits
- Complete detailed monitoring visit reports
- Track regulatory submissions and recruitment progress
- Manage CRF completion and data query resolution
- Maintain regular communication with clinical sites
- Ensure inspection readiness for all studies
- Facilitate site audits and oversight visits
- Escalate quality and GCP issues appropriately
- Attend disease-specific and general CRA training
Work Experience
- 2 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- Microsoft Word
- Excel
- MS Project
- MS PowerPoint
- Outlook
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BeOne Medicines Germany 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
BeOne Medicines Germany GmbH
Industry
Pharmaceuticals
Description
The company is focused on advancing public policy objectives and advocating for patient access to therapies in the healthcare sector.
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