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IQIQVIA RDS GmbH

Clinical Trial Coordinator – Early Clinical Trials(m/w/x)

Frankfurt am Main
Full-timeRemoteExperienced

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

  • EnglishBusiness Fluent
  • GermanBusiness Fluent

Tools & Technologies

  • MS Office
  • eTMF systems
  • Veeva
  • BIRDS
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