IQVIA
Clinical Research Associate I or II(m/w/x)
Vollzeit
mit Homeoffice
Junior
ab 3.600 / Monat
Wien
IQ
IQVIA Biotech22 Tage
Clinical Associate Regulatory Submissions(m/w/x)
Vollzeit
mit Homeoffice
Junior
Keine Angabe
Wien
Nejo KI-Zusammenfassung
In this role, you will engage in Site Activation activities while ensuring compliance with regulations. Your day-to-day responsibilities will include preparing regulatory submissions, coordinating with teams, and mentoring junior associates, all while maintaining project timelines.
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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
Bachelor-Abschluss
Berufserfahrung
1–3 Jahre
Deine 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
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.
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