PSI CRO
Central Monitoring Manager(m/w/x)
Full-timeOn-siteExperienced
Wien
from 70,000 / year
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TETeleflex Incorporated
Clinical Research Associate(m/w/x)
Wien
from 65,000 / year
Full-timeOn-siteExperienced
Nejo AI Summary
On-site and remote monitoring visits for medical device trials. Investigator file completion and quality issue escalation required. Home office setup, dedicated desk space, and company-provided equipment.
Requirements
- Minimum 2 years work experience as clinical trial monitor
- Bachelor's or Graduate degree in life sciences, nursing, health disciplines, or comparable qualification
- Minimum two years on-site monitoring research experience as CRA in medical device, pharmaceutical industry, or CRO
- High attention to detail and organizational ability
- Excellent people skills
- Excellent clinical trial monitoring skills
- Previous knowledge of Vascular Interventional Cardiology and/or Peripheral Vascular Intervention is an advantage
- Strong working knowledge of MDR, ISO 14155, ICH/GCP guidelines
- Strong compliance focus
- Aptitude and knowledge in relevant therapeutic areas
- Ability to learn and integrate new therapeutic areas knowledge
- Ability to train and mentor Clinical Studies personnel
- Ability to train on site staff on protocol, GCPs, data entry, regulations
- Ability to maintain composure in difficult circumstances
- Ability to adapt to shifting priorities and competing demands
- High attention to detail and accuracy
- Experience working independently in a regional area
- Remote or minimal supervision experience
- Proficient knowledge of medical terminology
- Effective time management skills
- Effective organizational skills
- Excellent professional writing skills
- Excellent oral communication skills
- Excellent interpersonal skills
- Experience with spreadsheets and databases applications
- Experience with MS Word and Excel
- Ability to work independently within Teleflex systems
- Ability to work independently
- Ability to work as part of a team
- Fluent (written and spoken) in German
- Fluent (written and spoken) in English
- International travel if necessary
Tasks
- Conduct monitoring visits within timelines and according to plans.
- Schedule and conduct on-site and remote monitoring visits.
- Evaluate site practices and escalate quality issues.
- Prepare for monitoring visits to ensure thorough and efficient activities.
- Complete Investigator Files with all required documentation.
- Present findings to site staff and provide retraining.
- Review data queries with site staff for resolution.
- Serve as a resource to clinical site staff between visits.
- Complete accurate and succinct Monitoring Visit Reports.
- Document monitoring visit action items clearly.
- Collect and file necessary documents.
- Ensure compliance with safety reporting requirements.
- Collect local safety reporting requirements and report to Safety Officer.
- Prepare national safety-related submission documents.
- Submit local safety documentation to EC/NCA.
- Follow up with study sites on safety-related tasks.
- Ensure compliance with safety event reporting processes.
- Collect local data protection requirement information.
- Assist Clinical Project Manager with study-related projects.
- Conduct co-monitoring to ensure consistency with protocols.
- Train and mentor new Clinical Studies personnel.
- Support safety inspections and audits by regulatory authorities.
Work Experience
- 2 years
Education
- Bachelor's degree
Languages
- German – Fluent
- English – Fluent
Tools & Technologies
- MDR
- ISO 14155
- ICH/GCP
- MS Word
- Excel
Benefits
Modern Equipment
- Home office setup
- Teleflex supplied equipment
Ergonomic Workplace
- Dedicated desk space
Job Security
- Permanent position
Other Benefits
- Diversity and inclusion initiatives
- Support for application accommodation
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Teleflex Incorporated 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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TETeleflex Incorporated
Clinical Research Associate(m/w/x)
Wien
from 65,000 / year
Full-timeOn-siteExperienced
Nejo AI Summary
On-site and remote monitoring visits for medical device trials. Investigator file completion and quality issue escalation required. Home office setup, dedicated desk space, and company-provided equipment.
Requirements
- Minimum 2 years work experience as clinical trial monitor
- Bachelor's or Graduate degree in life sciences, nursing, health disciplines, or comparable qualification
- Minimum two years on-site monitoring research experience as CRA in medical device, pharmaceutical industry, or CRO
- High attention to detail and organizational ability
- Excellent people skills
- Excellent clinical trial monitoring skills
- Previous knowledge of Vascular Interventional Cardiology and/or Peripheral Vascular Intervention is an advantage
- Strong working knowledge of MDR, ISO 14155, ICH/GCP guidelines
- Strong compliance focus
- Aptitude and knowledge in relevant therapeutic areas
- Ability to learn and integrate new therapeutic areas knowledge
- Ability to train and mentor Clinical Studies personnel
- Ability to train on site staff on protocol, GCPs, data entry, regulations
- Ability to maintain composure in difficult circumstances
- Ability to adapt to shifting priorities and competing demands
- High attention to detail and accuracy
- Experience working independently in a regional area
- Remote or minimal supervision experience
- Proficient knowledge of medical terminology
- Effective time management skills
- Effective organizational skills
- Excellent professional writing skills
- Excellent oral communication skills
- Excellent interpersonal skills
- Experience with spreadsheets and databases applications
- Experience with MS Word and Excel
- Ability to work independently within Teleflex systems
- Ability to work independently
- Ability to work as part of a team
- Fluent (written and spoken) in German
- Fluent (written and spoken) in English
- International travel if necessary
Tasks
- Conduct monitoring visits within timelines and according to plans.
- Schedule and conduct on-site and remote monitoring visits.
- Evaluate site practices and escalate quality issues.
- Prepare for monitoring visits to ensure thorough and efficient activities.
- Complete Investigator Files with all required documentation.
- Present findings to site staff and provide retraining.
- Review data queries with site staff for resolution.
- Serve as a resource to clinical site staff between visits.
- Complete accurate and succinct Monitoring Visit Reports.
- Document monitoring visit action items clearly.
- Collect and file necessary documents.
- Ensure compliance with safety reporting requirements.
- Collect local safety reporting requirements and report to Safety Officer.
- Prepare national safety-related submission documents.
- Submit local safety documentation to EC/NCA.
- Follow up with study sites on safety-related tasks.
- Ensure compliance with safety event reporting processes.
- Collect local data protection requirement information.
- Assist Clinical Project Manager with study-related projects.
- Conduct co-monitoring to ensure consistency with protocols.
- Train and mentor new Clinical Studies personnel.
- Support safety inspections and audits by regulatory authorities.
Work Experience
- 2 years
Education
- Bachelor's degree
Languages
- German – Fluent
- English – Fluent
Tools & Technologies
- MDR
- ISO 14155
- ICH/GCP
- MS Word
- Excel
Benefits
Modern Equipment
- Home office setup
- Teleflex supplied equipment
Ergonomic Workplace
- Dedicated desk space
Job Security
- Permanent position
Other Benefits
- Diversity and inclusion initiatives
- Support for application accommodation
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Teleflex Incorporated 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
Teleflex Incorporated
Industry
Healthcare
Description
Teleflex is a global provider of medical technologies focused on improving health and quality of life through innovative solutions.
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