IQVIA
Clinical Research Associate I or II(m/w/x)
Full-timeWith HomeofficeJunior
Wien
from 3,600 / month
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IQIQVIA Biotech
Clinical Associate Regulatory Submissions(m/w/x)
Wien
Full-timeWith Home OfficeJunior
Nejo AI Summary
Site activation and start-up activities for biotech and biopharma clinical trials. EU CTR experience for Germany and Austria, plus 1-3 years in clinical research, required. Diverse project portfolio across 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 Site Activation activities in compliance with local and international regulations
- Serve as the Single Point of Contact for assigned studies
- Ensure adherence to standard operating procedures and project timelines
- Prepare and submit regulatory documents to relevant authorities
- Conduct feasibility, site identification, and start-up activities
- Distribute completed documents to sites and internal teams
- Review site documents for completeness and accuracy
- Track and follow up on the approval and execution of various documents
- Inform team members of the completion of regulatory and contractual documents
- Provide local expertise during project timeline planning
- Perform quality control on documents submitted by sites
- Mentor junior Clinical Associates and act as a subject matter expert
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.
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IQIQVIA Biotech
Clinical Associate Regulatory Submissions(m/w/x)
Wien
Full-timeWith Home OfficeJunior
Nejo AI Summary
Site activation and start-up activities for biotech and biopharma clinical trials. EU CTR experience for Germany and Austria, plus 1-3 years in clinical research, required. Diverse project portfolio across 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 Site Activation activities in compliance with local and international regulations
- Serve as the Single Point of Contact for assigned studies
- Ensure adherence to standard operating procedures and project timelines
- Prepare and submit regulatory documents to relevant authorities
- Conduct feasibility, site identification, and start-up activities
- Distribute completed documents to sites and internal teams
- Review site documents for completeness and accuracy
- Track and follow up on the approval and execution of various documents
- Inform team members of the completion of regulatory and contractual documents
- Provide local expertise during project timeline planning
- Perform quality control on documents submitted by sites
- Mentor junior Clinical Associates and act as a subject matter expert
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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
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?
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