IQVIA
Clinical Research Associate I or II(m/w/x)
Vollzeitmit HomeofficeJunior
Wien
ab 3.600 / Monat
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IQIQVIA Biotech
Clinical Associate Regulatory Submissions(m/w/x)
Wien
Vollzeitmit HomeofficeJunior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 1 - 3 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens IQVIA Biotech 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?
- IQVIA Biotech
Clinical Research Associate 2(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenWienab 4.000 / Monat - AOP Health
Clinical Site Management Lead(m/w/x)
Vollzeitmit HomeofficeSeniorWienab 45.080 / Jahr - IQVIA
Clinical Research Associate II or Senior Clinical Research Associate I(m/w/x)
Vollzeitmit HomeofficeSeniorWienab 4.200 / Monat - PSI CRO
Site Identification Specialist(m/w/x)
Vollzeitmit HomeofficeJuniorWienab 70.000 / Jahr
IQIQVIA Biotech
Clinical Associate Regulatory Submissions(m/w/x)
Wien
Vollzeitmit HomeofficeJunior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 1 - 3 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens IQVIA Biotech 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
IQVIA Biotech
Branche
Healthcare
Beschreibung
The company partners with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas.
Noch nicht perfekt?
- IQVIA
Clinical Research Associate I or II(m/w/x)
Vollzeitmit HomeofficeJuniorWienab 3.600 / Monat - IQVIA Biotech
Clinical Research Associate 2(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenWienab 4.000 / Monat - AOP Health
Clinical Site Management Lead(m/w/x)
Vollzeitmit HomeofficeSeniorWienab 45.080 / Jahr - IQVIA
Clinical Research Associate II or Senior Clinical Research Associate I(m/w/x)
Vollzeitmit HomeofficeSeniorWienab 4.200 / Monat - PSI CRO
Site Identification Specialist(m/w/x)
Vollzeitmit HomeofficeJuniorWienab 70.000 / Jahr