Clinical Trial Coordinator
Merck
Merck seeks a Clinical Trial Coordinator in Copenhagen to manage multi-country clinical trial operations, including site administration, document management, regulatory compliance, and stakeholder coordination across internal teams and external sites.
Responsibilities
- Coordinate site readiness, provisioning, and logistics for clinical/non-clinical supplies across multiple countries
- Prepare, archive, and reconcile electronic Trial Master Files for regulatory inspection readiness
- Manage country and site document collection for validation, start-up, and regulatory submissions
- Track essential documents, safety updates, and maintain investigator site files to ensure data integrity
- Support budget development, contract coordination, and payment execution while ensuring compliance
Requirements
- Bachelor's degree in life sciences, health-related field, or training in office management, administration, finance, or healthcare
- Clinical research environment experience with understanding of drug development processes
- Knowledge of ICH-GCP, Good Documentation Practices, and applicable regulations
- Fluency in English and Danish; ability to work independently and in cross-functional, multicultural teams
- Proficiency with Clinical Trial Management Systems (CTMS), electronic Trial Master Files (eTMF), and core digital tools
- Strong organizational skills with meticulous attention to detail and ability to manage shifting priorities
- Analytical problem-solving capability with data-driven decision-making approach
Ledig stilling opslået Indrykket for 4 dage siden
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