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Global Clinical Trial Coordinator(m/w/x)
Coordinating early clinical trials for sponsors and study sites, managing documentation and data in electronic systems. 5+ years in clinical research coordination with GCP/ICH knowledge required. Mentoring program available.
Anforderungen
- Bachelor’s or higher-level degree in Business Administration, Life Science or equivalent
- Vocational training with extensive experience in clinical and regulatory environments
- At least 5 years’ experience as Clinical Trial Coordinator or similar role in clinical research
- Strong knowledge of clinical research regulatory requirements, i.e., GCP and ICH guidelines
- Excellent administrative and organizational skills
- Strong communication and interpersonal skills
- Proficiency in MS Office and eTMF systems (e.g., Veeva, BIRDS)
- Fluent language skills in German on at least C1 level
- Good command of English
- Ability to work independently, prioritize tasks, and manage multiple projects
Aufgaben
- Coordinate early clinical trials for sponsors and study sites
- Support Clinical Trial Leaders and Managers in study activities
- Prepare and manage clinical trial documentation
- Compile and collect submission documents
- Maintain trial-specific data and timelines in electronic systems
- Communicate with internal and external partners
- Organize and monitor study-related activities and meetings
- Ensure timely preparation of submission documents for authorities
- Manage essential documents for Investigator Site File
- Ensure Trial Master File completeness and compliance
- Oversee TMF strategy and perform quality checks
- Maintain List of Expected Records for TMF
- Ensure audit and inspection readiness
- Participate in process harmonization initiatives
- Support implementation of new systems
- Assist in finalizing Clinical Trial Reports and appendices
Berufserfahrung
- 5 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- MS Office
- eTMF systems
- Veeva
- BIRDS
Benefits
Weiterbildungsangebote
- In-depth training
Mentoring & Coaching
- Mentoring
Attraktive Vergütung
- Competitive salary
Sonstige Vorteile
- Benefits package
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Global Clinical Trial Coordinator(m/w/x)
Coordinating early clinical trials for sponsors and study sites, managing documentation and data in electronic systems. 5+ years in clinical research coordination with GCP/ICH knowledge required. Mentoring program available.
Anforderungen
- Bachelor’s or higher-level degree in Business Administration, Life Science or equivalent
- Vocational training with extensive experience in clinical and regulatory environments
- At least 5 years’ experience as Clinical Trial Coordinator or similar role in clinical research
- Strong knowledge of clinical research regulatory requirements, i.e., GCP and ICH guidelines
- Excellent administrative and organizational skills
- Strong communication and interpersonal skills
- Proficiency in MS Office and eTMF systems (e.g., Veeva, BIRDS)
- Fluent language skills in German on at least C1 level
- Good command of English
- Ability to work independently, prioritize tasks, and manage multiple projects
Aufgaben
- Coordinate early clinical trials for sponsors and study sites
- Support Clinical Trial Leaders and Managers in study activities
- Prepare and manage clinical trial documentation
- Compile and collect submission documents
- Maintain trial-specific data and timelines in electronic systems
- Communicate with internal and external partners
- Organize and monitor study-related activities and meetings
- Ensure timely preparation of submission documents for authorities
- Manage essential documents for Investigator Site File
- Ensure Trial Master File completeness and compliance
- Oversee TMF strategy and perform quality checks
- Maintain List of Expected Records for TMF
- Ensure audit and inspection readiness
- Participate in process harmonization initiatives
- Support implementation of new systems
- Assist in finalizing Clinical Trial Reports and appendices
Berufserfahrung
- 5 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- MS Office
- eTMF systems
- Veeva
- BIRDS
Benefits
Weiterbildungsangebote
- In-depth training
Mentoring & Coaching
- Mentoring
Attraktive Vergütung
- Competitive salary
Sonstige Vorteile
- Benefits package
Über das Unternehmen
IQVIA
Branche
Healthcare
Beschreibung
IQVIA is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients.
Noch nicht perfekt?
- IQVIA
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Experienced Clinical Trials Assistant(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenFrankfurt am Main - IQVIA RDS GmbH
Local Trial Manager(m/w/x)
Vollzeitmit HomeofficeSeniorFrankfurt am Main - IQVIA RDS GmbH
Clinical Trial Manager - Single Sponsor dedicated(m/w/x)
VollzeitRemoteBerufserfahrenFrankfurt am Mainab 70.100 / Jahr