Dein persönlicher KI-Karriere-Agent
Clinical Trial Coordinator – Early Clinical Trials(m/w/x)
Coordinating early-phase clinical trials for sponsors and sites, managing documentation and electronic data. Extensive clinical and regulatory experience with GCP/ICH knowledge required. Support for Clinical Trial Leaders and Investigators.
Anforderungen
- Bachelor’s degree in Business Administration or equivalent
- Experience in clinical trials
- Vocational training with extensive experience
- Extensive experience in clinical and regulatory environments
- Strong knowledge of GCP and ICH guidelines
- Excellent administrative and organizational skills
- Strong communication and interpersonal skills
- Proficiency in MS Office
- Proficiency in eTMF systems (Veeva, BIRDS)
- Fluent English
- Fluent German
- Ability to work independently
- Ability to prioritize tasks
- Ability to manage multiple projects
- Experience in complex international environment
Aufgaben
- Coordinate early clinical trials for sponsors and study sites
- Support Clinical Trial Leaders, Managers, and Investigators 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
- Prepare submission documents for authorities and ethics committees
- Manage essential documents for Investigator Site File (ISF)
- Ensure Trial Master File (TMF) completeness and compliance
- Oversee TMF strategy and perform quality checks
- Maintain List of Expected Records
- Ensure audit and inspection readiness
- Participate in process harmonization initiatives
- Support implementation of new systems
- Assist in finalizing Clinical Trial Reports (CTR) and appendices
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- MS Office
- eTMF systems
- Veeva
- BIRDS
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Noch nicht perfekt?
- IQVIAVollzeitmit HomeofficeSeniorFrankfurt am Main
- IQVIA
Experienced Clinical Trial Coordinator(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenFrankfurt am Main - IQVIA
Experienced Clinical Trials Assistant(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenFrankfurt am Main - IQVIA RDS GmbH
Clinical Trial Manager - Single Sponsor dedicated(m/w/x)
VollzeitRemoteBerufserfahrenFrankfurt am Mainab 70.100 / Jahr - IQVIA
Experienced Clinical Trials Assistant(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenFrankfurt am Main, Hamburg
Clinical Trial Coordinator – Early Clinical Trials(m/w/x)
Coordinating early-phase clinical trials for sponsors and sites, managing documentation and electronic data. Extensive clinical and regulatory experience with GCP/ICH knowledge required. Support for Clinical Trial Leaders and Investigators.
Anforderungen
- Bachelor’s degree in Business Administration or equivalent
- Experience in clinical trials
- Vocational training with extensive experience
- Extensive experience in clinical and regulatory environments
- Strong knowledge of GCP and ICH guidelines
- Excellent administrative and organizational skills
- Strong communication and interpersonal skills
- Proficiency in MS Office
- Proficiency in eTMF systems (Veeva, BIRDS)
- Fluent English
- Fluent German
- Ability to work independently
- Ability to prioritize tasks
- Ability to manage multiple projects
- Experience in complex international environment
Aufgaben
- Coordinate early clinical trials for sponsors and study sites
- Support Clinical Trial Leaders, Managers, and Investigators 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
- Prepare submission documents for authorities and ethics committees
- Manage essential documents for Investigator Site File (ISF)
- Ensure Trial Master File (TMF) completeness and compliance
- Oversee TMF strategy and perform quality checks
- Maintain List of Expected Records
- Ensure audit and inspection readiness
- Participate in process harmonization initiatives
- Support implementation of new systems
- Assist in finalizing Clinical Trial Reports (CTR) and appendices
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- MS Office
- eTMF systems
- Veeva
- BIRDS
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
IQVIA RDS GmbH
Branche
Healthcare
Beschreibung
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.
Noch nicht perfekt?
- IQVIA
Global Clinical Trial Coordinator(m/w/x)
Vollzeitmit HomeofficeSeniorFrankfurt am Main - IQVIA
Experienced Clinical Trial Coordinator(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenFrankfurt am Main - IQVIA
Experienced Clinical Trials Assistant(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenFrankfurt am Main - IQVIA RDS GmbH
Clinical Trial Manager - Single Sponsor dedicated(m/w/x)
VollzeitRemoteBerufserfahrenFrankfurt am Mainab 70.100 / Jahr - IQVIA
Experienced Clinical Trials Assistant(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenFrankfurt am Main, Hamburg