Clinical Trial Coordinator - FSP (m/f/d)
Core
Provide administrative and technical support to clinical trial project teams, ensuring audit readiness and managing study documentation.
Role type
Clinical Trial Coordinator (Administrative & Technical Support)
Builds
Clinical trial documentation, regulatory submissions, and study metrics reports
Domain
Clinical Research / Life Sciences
Deliverable
dashboards & analysis
Required skills
Organizational skills, attention to detail, data analysis, knowledge of ICH GCP and country regulations, English (fluent), German (C1)
Preferred skills
Digital literacy, MS Office proficiency, ability to master clinical trial database systems
Technologies
GoBalto, eTMF, MS Office (Word, Excel, PowerPoint)
Responsibilities
Perform department, Internal, Country, and Investigator file reviews; ensure tasks are performed on time and within budget; maintain study-specific documentation and systems; support RBM activities; process documents for (e)TMF; transmit documents to client and IRB/IEC; analyze and reconcile study metrics; assist with ISF and Pharmacy binder materials; support study-specific translation and QC.
Seniority
Individual Contributor