BeOne Medicines Germany GmbH
Clinical Research Associate(m/w/x)
Full-timeRemoteExperienced
Hamburg, Bremen, Berlin
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IQIQVIA Biotech
Clinical Associate Submissions – Regulatory(m/w/x)
Berlin
Full-timeWith Home OfficeJunior
Nejo AI Summary
Preparing and submitting regulatory documents for clinical trial site activation at biotech and biopharma partners. EU CTR experience for Germany and Austria, plus local language proficiency, required. Diverse clinical development projects across all phases and therapeutic areas.
Requirements
- EU CTR experience for Germany and Austria
- Local language proficiency
- Knowledge of national requirements
- B Sc degree in Health Sciences or related field
- 1 - 3 years' relevant clinical research experience
- Experience in EUCTR and CTIS submission procedures
- Feasibility and Country Inform Consent adaptation for DACH regions
- Experience in Site Contract negotiations with DACH sites
- Experience in medical device submissions is beneficial
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Good negotiating and communication skills in local language
- Effective communication, organizational, and interpersonal skills
- Ability to work independently and to effectively prioritize tasks
- Ability to manage multiple projects
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- Understanding of regulated clinical trial environment and knowledge of drug development process
Tasks
- Perform country-level tasks for Site Activation activities
- Ensure compliance with local and international regulations
- Adhere to standard operating procedures (SOPs) and project requirements
- Prepare and submit documents to regulatory bodies
- Conduct feasibility and site identification activities
- Manage site activation activities according to regulations and SOPs
- Distribute completed documents to sites and project team members
- Review site documents for completeness and accuracy
- Track and follow up on document approvals and executions
- Inform team members of document completion for individual sites
- Provide local expertise to Site Activation Managers and project teams
- Perform quality control on documents from sites
- Act as a subject matter expert on specific topics
- Mentor junior Clinical Associates
Work Experience
- 1 - 3 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of IQVIA Biotech 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.
Not a perfect match?
- BeOne Medicines Germany GmbH
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IQIQVIA Biotech
Clinical Associate Submissions – Regulatory(m/w/x)
Berlin
Full-timeWith Home OfficeJunior
Nejo AI Summary
Preparing and submitting regulatory documents for clinical trial site activation at biotech and biopharma partners. EU CTR experience for Germany and Austria, plus local language proficiency, required. Diverse clinical development projects across all phases and therapeutic areas.
Requirements
- EU CTR experience for Germany and Austria
- Local language proficiency
- Knowledge of national requirements
- B Sc degree in Health Sciences or related field
- 1 - 3 years' relevant clinical research experience
- Experience in EUCTR and CTIS submission procedures
- Feasibility and Country Inform Consent adaptation for DACH regions
- Experience in Site Contract negotiations with DACH sites
- Experience in medical device submissions is beneficial
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Good negotiating and communication skills in local language
- Effective communication, organizational, and interpersonal skills
- Ability to work independently and to effectively prioritize tasks
- Ability to manage multiple projects
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- Understanding of regulated clinical trial environment and knowledge of drug development process
Tasks
- Perform country-level tasks for Site Activation activities
- Ensure compliance with local and international regulations
- Adhere to standard operating procedures (SOPs) and project requirements
- Prepare and submit documents to regulatory bodies
- Conduct feasibility and site identification activities
- Manage site activation activities according to regulations and SOPs
- Distribute completed documents to sites and project team members
- Review site documents for completeness and accuracy
- Track and follow up on document approvals and executions
- Inform team members of document completion for individual sites
- Provide local expertise to Site Activation Managers and project teams
- Perform quality control on documents from sites
- Act as a subject matter expert on specific topics
- Mentor junior Clinical Associates
Work Experience
- 1 - 3 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of IQVIA Biotech 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
IQVIA Biotech
Industry
Healthcare
Description
The company partners with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas.
Not a perfect match?
- BeOne Medicines Germany GmbH
Clinical Research Associate(m/w/x)
Full-timeRemoteExperiencedHamburg, Bremen, Berlin - BeOne Medicines Germany GmbH
Senior Clinical Research Associate(m/w/x)
Full-timeRemoteSeniorHamburg, Bremen, Berlin - Clinische Studien Gesellschaft (CSG)
Clinical Research Associate / Klinischer Monitor(m/w/x)
Full-timeWith HomeofficeExperiencedBerlin - Immatics Biotechnologies GmbH
Medical Monitor*(m/w/x)
Full-time/Part-timeWith HomeofficeExperiencedTübingen, München, Berlin - Takeda
Associate Director, Study Site Engagement(m/w/x)
Full-timeWith HomeofficeSeniorBerlin