IQVIA Biotech
Clinical Research Associate 2(m/w/x)
Full-timeWith HomeofficeExperienced
Wien
from 4,000 / month
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IQIQVIA
Local Trial Manager - Sponsor Dedicated(m/w/x)
Wien
from 70,100 / year
Full-timeRemoteSenior
Nejo AI Summary
Country-level oversight of oncology clinical trials including budget proposals and external service provider contract management. Minimum 5 years clinical research and 1-3 years local trial management experience required. Primary point of contact for site-specific regulatory compliance and GCP adherence.
Requirements
- Master’s or higher-level life science degree
- 5 years clinical research experience
- 1-3 years local trial management experience
- Therapeutic area expertise in Oncology
- Knowledge of GCP and ICH guidelines
- Fluent German and good English command
- Strong IT and software skills
- Decision-making and financial management skills
- Flexibility and virtual team management
- Willingness to travel occasionally
Tasks
- Adhere to SOPs, GCP codes, and local regulatory requirements
- Prepare high-level and detailed budget proposals
- Manage external service provider contracts and change orders
- Ensure services are delivered according to contract terms
- Act as the primary country-level contact for assigned trials
- Track project progress against planned timelines
- Monitor patient recruitment to meet enrollment targets
- Maintain and update trial management systems
- Analyze trial progress using study tools and reports
- Prepare for and conduct Health Authority inspections
- Support internal Quality Assurance audits
- Develop site-level recruitment strategies and contingency plans
- Manage country-level vendors to support study execution
- Submit requests for and assist in vendor selection
- Review country-specific informed consent documents
- Report AEs, SAEs, and PQCs within required timelines
- Maintain accurate data in CTMS and VTMF systems
- Ensure inspection readiness and document archiving compliance
- Implement CAPAs for audits and quality issues
- Collaborate with Global Trial and Clinical Project Leads
- Forecast and manage local trial budgets proactively
- Ensure accurate and timely finance reporting
- Negotiate trial site contracts and budgets
- Organize and secure IEC and Health Authority approvals
- Mentor staff or represent functional areas in process initiatives
Work Experience
- 5 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- GCP
- ICH guidelines
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of IQVIA 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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Clinical Site Management Lead(m/w/x)
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IQIQVIA
Local Trial Manager - Sponsor Dedicated(m/w/x)
Wien
from 70,100 / year
Full-timeRemoteSenior
Nejo AI Summary
Country-level oversight of oncology clinical trials including budget proposals and external service provider contract management. Minimum 5 years clinical research and 1-3 years local trial management experience required. Primary point of contact for site-specific regulatory compliance and GCP adherence.
Requirements
- Master’s or higher-level life science degree
- 5 years clinical research experience
- 1-3 years local trial management experience
- Therapeutic area expertise in Oncology
- Knowledge of GCP and ICH guidelines
- Fluent German and good English command
- Strong IT and software skills
- Decision-making and financial management skills
- Flexibility and virtual team management
- Willingness to travel occasionally
Tasks
- Adhere to SOPs, GCP codes, and local regulatory requirements
- Prepare high-level and detailed budget proposals
- Manage external service provider contracts and change orders
- Ensure services are delivered according to contract terms
- Act as the primary country-level contact for assigned trials
- Track project progress against planned timelines
- Monitor patient recruitment to meet enrollment targets
- Maintain and update trial management systems
- Analyze trial progress using study tools and reports
- Prepare for and conduct Health Authority inspections
- Support internal Quality Assurance audits
- Develop site-level recruitment strategies and contingency plans
- Manage country-level vendors to support study execution
- Submit requests for and assist in vendor selection
- Review country-specific informed consent documents
- Report AEs, SAEs, and PQCs within required timelines
- Maintain accurate data in CTMS and VTMF systems
- Ensure inspection readiness and document archiving compliance
- Implement CAPAs for audits and quality issues
- Collaborate with Global Trial and Clinical Project Leads
- Forecast and manage local trial budgets proactively
- Ensure accurate and timely finance reporting
- Negotiate trial site contracts and budgets
- Organize and secure IEC and Health Authority approvals
- Mentor staff or represent functional areas in process initiatives
Work Experience
- 5 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- GCP
- ICH guidelines
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of IQVIA 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
Industry
Healthcare
Description
IQVIA is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients.
Not a perfect match?
- IQVIA Biotech
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Clinical Research Associate II or Senior Clinical Research Associate I(m/w/x)
Full-timeWith HomeofficeSeniorWienfrom 4,200 / month - AOP Health
Clinical Site Management Lead(m/w/x)
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Clinical Associate Regulatory Submissions(m/w/x)
Full-timeWith HomeofficeJuniorWien