When our values align, there's no limit to what we can achieve.
 

• Assists in coordination and administration of clinical studies from the start-up to execution and closeout

• Collects, assists in preparation, reviews and tracks documents for the application process. Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.

• Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.

• Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study.

• Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements.

• Ensures essential documents under their responsibility ar...