PSI CRO
Central Monitoring Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Wien
ab 70.000 / Jahr
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
TETeleflex Incorporated
Clinical Research Associate(m/w/x)
Wien
ab 65.000 / Jahr
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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.
Berufserfahrung
- 2 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – fließend
- Englisch – fließend
Tools & Technologien
- MDR
- ISO 14155
- ICH/GCP
- MS Word
- Excel
Benefits
Moderne Technikausstattung
- Home office setup
- Teleflex supplied equipment
Ergonomischer Arbeitsplatz
- Dedicated desk space
Sicherer Arbeitsplatz
- Permanent position
Sonstige Vorteile
- Diversity and inclusion initiatives
- Support for application accommodation
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Teleflex Incorporated erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- PSI CRO
Clinical Site Coordinator(m/w/x)
Vollzeitnur vor OrtBerufserfahrenWien - QEH IQVIA RDS Eastern Holdings GmbH
Site Activation & Administrative Coordinator(m/w/x)
Vollzeitnur vor OrtKeine AngabeWien - IQVIA
Regulatory Affairs Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenWien - Roche Austria GmbH
Country Study Manager(m/w/x)
Vollzeitnur vor OrtSeniorWienab 63.000 / Jahr
TETeleflex Incorporated
Clinical Research Associate(m/w/x)
Wien
ab 65.000 / Jahr
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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.
Berufserfahrung
- 2 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – fließend
- Englisch – fließend
Tools & Technologien
- MDR
- ISO 14155
- ICH/GCP
- MS Word
- Excel
Benefits
Moderne Technikausstattung
- Home office setup
- Teleflex supplied equipment
Ergonomischer Arbeitsplatz
- Dedicated desk space
Sicherer Arbeitsplatz
- Permanent position
Sonstige Vorteile
- Diversity and inclusion initiatives
- Support for application accommodation
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Teleflex Incorporated erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Teleflex Incorporated
Branche
Healthcare
Beschreibung
Teleflex is a global provider of medical technologies focused on improving health and quality of life through innovative solutions.
Noch nicht perfekt?
- PSI CRO
Central Monitoring Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahrenWienab 70.000 / Jahr - PSI CRO
Clinical Site Coordinator(m/w/x)
Vollzeitnur vor OrtBerufserfahrenWien - QEH IQVIA RDS Eastern Holdings GmbH
Site Activation & Administrative Coordinator(m/w/x)
Vollzeitnur vor OrtKeine AngabeWien - IQVIA
Regulatory Affairs Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenWien - Roche Austria GmbH
Country Study Manager(m/w/x)
Vollzeitnur vor OrtSeniorWienab 63.000 / Jahr