IQVIA RDS GmbH
Experienced Clinical Research Associate, Multi-Sponsor(m/w/x)
Full-timeWith HomeofficeExperienced
Frankfurt am Main
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IQIQVIA
Study Site Management Specialist(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Managing country-level site activation and ongoing maintenance, acting as primary contact for investigative sites. 3 years’ clinical research experience and German fluency required. Work in a human data science environment focused on healthcare solutions.
Requirements
- German language fluency
- Local submissions experience
- Bachelor’s Degree in life sciences, related field, or equivalent
- 3 years’ clinical research, relevant experience, or equivalent
- In-depth knowledge of clinical systems
- Knowledge of procedures and corporate standards
- Ability to apply GCP/ICH and regulatory guidelines
- Knowledge of local regulations and SOPs
- Understanding of regulated clinical trial environment
- Knowledge of drug development process
Tasks
- Execute country-level site activation activities
- Follow local and international regulatory guidelines
- Adhere to SOPs and project requirements
- Perform ongoing site maintenance activities
- Act as the primary contact for investigative sites
- Coordinate with project management and internal departments
- Ensure quality of deliverables and project timelines
- Distribute completed documents to sites and teams
- Prepare and review site regulatory documents
- Maintain internal systems and tracking tools
- Provide feedback on site performance metrics
- Establish and agree on project planning timelines
- Implement monitoring measures and contingency plans
- Track progress of ethics and regulatory approvals
- Manage Informed Consent Form and Investigator Pack release
- Offer local expertise during project timeline planning
- Conduct quality control on site-provided documentation
- Communicate directly with sponsors on specific initiatives
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
Tools & Technologies
- GCP
- ICH
- SOPs
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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IQIQVIA
Study Site Management Specialist(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Managing country-level site activation and ongoing maintenance, acting as primary contact for investigative sites. 3 years’ clinical research experience and German fluency required. Work in a human data science environment focused on healthcare solutions.
Requirements
- German language fluency
- Local submissions experience
- Bachelor’s Degree in life sciences, related field, or equivalent
- 3 years’ clinical research, relevant experience, or equivalent
- In-depth knowledge of clinical systems
- Knowledge of procedures and corporate standards
- Ability to apply GCP/ICH and regulatory guidelines
- Knowledge of local regulations and SOPs
- Understanding of regulated clinical trial environment
- Knowledge of drug development process
Tasks
- Execute country-level site activation activities
- Follow local and international regulatory guidelines
- Adhere to SOPs and project requirements
- Perform ongoing site maintenance activities
- Act as the primary contact for investigative sites
- Coordinate with project management and internal departments
- Ensure quality of deliverables and project timelines
- Distribute completed documents to sites and teams
- Prepare and review site regulatory documents
- Maintain internal systems and tracking tools
- Provide feedback on site performance metrics
- Establish and agree on project planning timelines
- Implement monitoring measures and contingency plans
- Track progress of ethics and regulatory approvals
- Manage Informed Consent Form and Investigator Pack release
- Offer local expertise during project timeline planning
- Conduct quality control on site-provided documentation
- Communicate directly with sponsors on specific initiatives
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
Tools & Technologies
- GCP
- ICH
- SOPs
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.
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