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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.
Requirements
- 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
Tasks
- 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
Work Experience
- approx. 1 - 4 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- MS Office
- eTMF systems
- Veeva
- BIRDS
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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.
Requirements
- 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
Tasks
- 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
Work Experience
- approx. 1 - 4 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- MS Office
- eTMF systems
- Veeva
- BIRDS
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
IQVIA RDS GmbH
Industry
Healthcare
Description
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.
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