Clinical Study Admininstrator (m/f)

Job type:
on-site
Start:
asap
Duration:
24 MM
From:
Hays AG
Place:
near Bern
Date:
07/16/2014
Country:
flag_no Switzerland
project ID:
742952

Warning
This project is archived and not active any more.
You will find vacant projects in our project database.

We are looking for a
Clinical Study Admininstrator (m/f)

Reference: en
Start: asap
Duration: 24 MM
Place: near Bern
Branch: Tabakverarbeitung

Your tasks:
  • Support o the Clinical Study Team (organization of meetings, coordination of document reviews)
  • Set-up of paper and electronic Study Master File (SMF)
  • Ensure that SMF agreements are executed with CROs and followed throughout the study
  • Ensure SMFs transfers and check completeness of the SMFs upon receipt
  • Check completeness of the SMFs upon receipt form external partners and ensures that any missing documents are obtained
  • Archive documents electronically in DMS and ensure that documents in DMS are consistent with paper SMF
  • Archiving of paper SMFs
  • Assures QC checks of selected study documents
  • Provide support to the preparation and maintenance of the GCP training program for the clinical team
  • Support preparation, revision and editing of SOPs
  • Track all invoices related to clinical contracts
  • Stay up to date with ICH GCP knowledge
  • Supervision of one administrative staff


Your qualifications
  • Profound experience in the field of clinical study administration required (CRO, Pharmaceutical, Biotech, Medical Device industry)
  • Previous experience in Quality Assurance/Quality Control is an advantage
  • Knowledge of Documentum or other Document Management System (DMS) is an advantage
  • Fluent English (oral and written)
  • Strong interpersonal skills and strong team player
  • Good knowledge of MS Office Suite, capacity to learn the use of other IT tools
  • Knowledge of other languages (e.g. Japanese) is an advantage



Skills:
- Clinical trial associate
- Clinical trial assistant