BeOne Medicines Germany GmbH
Clinical Research Associate(m/w/x)
Full-timeRemoteExperienced
Hamburg, Bremen, Berlin
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BEBeOne Medicines Germany GmbH
Senior Clinical Research Associate(m/w/x)
Hamburg, Bremen, Berlin
Full-timeRemoteSenior
Nejo AI Summary
Clinical monitoring and site selection for oncology trials, advancing patient access to therapies. 3-5 years clinical monitoring experience in oncology trials required. Work focused on public policy and patient therapy access.
Requirements
- BS in scientific or healthcare discipline preferred
- At least 3-5 years monitoring experience
- Experience in oncology/onco-hematology global trials preferred
- Advanced knowledge of clinical research regulations
- 3-5 years CRA monitoring experience
- Experience in oncology/onco-hematology trials preferred
- Excellent communication and interpersonal skills
- Ability to maintain effective stakeholder relationships
- Excellent organizational and problem-solving skills
- Effective time management skills
- Good command of English and German
- Efficiency in Microsoft Office and hardware
Tasks
- Execute clinical monitoring per ICH and GCP guidelines
- Perform site selection and evaluation activities
- Manage oncology trial initiation and conduct
- Collaborate with regional study teams on timelines
- Identify gaps and propose corrective actions
- Provide local expertise for study start-up
- Complete therapeutic and protocol-specific training
- Deliver protocol training to assigned sites
- Conduct onsite and remote monitoring visits
- Document site findings and generate follow-up letters
- Track regulatory submissions and recruitment progress
- Manage CRF completion and data query resolution
- Maintain Trial Master Files and Investigator Site Files
- Ensure inspection readiness for studies and sites
- Report site progress to Clinical Operations
- Facilitate site audits and compliance visits
- Evaluate the integrity of site practices
- Escalate quality and GCP issues to investigators
- Mentor and buddy junior clinical research staff
- Act as escalation point for site-related concerns
- Review visit reports and identify significant risks
- Serve as subject matter expert for clinical operations
Work Experience
- 3 - 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- Good Clinical Practice (GCP)
- International Conference on Harmonization (ICH) guidelines
- Microsoft Word
- Excel
- PowerPoint
- Outlook
- Laptop computer
- iPhone
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
Senior Clinical Research Associate(m/w/x)
Hamburg, Bremen, Berlin
Full-timeRemoteSenior
Nejo AI Summary
Clinical monitoring and site selection for oncology trials, advancing patient access to therapies. 3-5 years clinical monitoring experience in oncology trials required. Work focused on public policy and patient therapy access.
Requirements
- BS in scientific or healthcare discipline preferred
- At least 3-5 years monitoring experience
- Experience in oncology/onco-hematology global trials preferred
- Advanced knowledge of clinical research regulations
- 3-5 years CRA monitoring experience
- Experience in oncology/onco-hematology trials preferred
- Excellent communication and interpersonal skills
- Ability to maintain effective stakeholder relationships
- Excellent organizational and problem-solving skills
- Effective time management skills
- Good command of English and German
- Efficiency in Microsoft Office and hardware
Tasks
- Execute clinical monitoring per ICH and GCP guidelines
- Perform site selection and evaluation activities
- Manage oncology trial initiation and conduct
- Collaborate with regional study teams on timelines
- Identify gaps and propose corrective actions
- Provide local expertise for study start-up
- Complete therapeutic and protocol-specific training
- Deliver protocol training to assigned sites
- Conduct onsite and remote monitoring visits
- Document site findings and generate follow-up letters
- Track regulatory submissions and recruitment progress
- Manage CRF completion and data query resolution
- Maintain Trial Master Files and Investigator Site Files
- Ensure inspection readiness for studies and sites
- Report site progress to Clinical Operations
- Facilitate site audits and compliance visits
- Evaluate the integrity of site practices
- Escalate quality and GCP issues to investigators
- Mentor and buddy junior clinical research staff
- Act as escalation point for site-related concerns
- Review visit reports and identify significant risks
- Serve as subject matter expert for clinical operations
Work Experience
- 3 - 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- Good Clinical Practice (GCP)
- International Conference on Harmonization (ICH) guidelines
- Microsoft Word
- Excel
- PowerPoint
- Outlook
- Laptop computer
- iPhone
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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