study administrator à Neuchatel

publié
contact
Barbara Sorce, Bâle Professionals Health Care & Life Sciences
type d'emploi
contract
postuler >

job details

publié
lieu
neuchatel, neuchâtel
secteur
Life Sciences
type d'emploi
contract
référence
11484
contact
barbara sorce, bâle professionals health care & life sciences
téléphone
058 201 55 50
postuler >

description du poste

   
 

Our client, a leading international tobacco company, with seven of world's top 15 brands, including the world's number one brand is looking for an

                                        Study Administrator

Location: Neuchâtel, Switzerland

Contract: 1 year with possibility of extension

Start Date: October 2018

Position Purpose / duties:

  • Set-up, maintenance and Quality Control (QC) of Study Master Files (SMFs) (paper and/or electronic) as per SMF Plans
  • Set-up of study mailboxes and study workpoints
  • Perform QC checks of study documents
  • Ensure reconciliation and QC of the SMFs upon transfer to the client from external parties such as CROs / sites / laboratories upon study completion
  • Ensure that Good Document Management Practices, company's policies, Standard Operating Procedures (SOPs), Work Instructions (WKIs) and ICH GCP standards are followed in management of SMFs
  • Provide support in creating / maintaining study document templates in the Electronic Document Management System (EDMS)
  • For assigned studies verify invoices sent from CROs/labs/third party Vendors
  • Assist Study Managers in the development and review of SMF plans
  • Archive SMFs electronically in EDMS and ensure that documents in EDMS are consistent with paper SMF
  • Archive paper SMFs in internal Archive
  • Act as back-up for the e-SMF study administrator
  • Support Clinical Assessment team in the preparation of any audits and Inspections; coordinates collection of documents, meetings etc. as required
  • Stay up to date with ICH GCP knowledge

 Qualifications needed

  • 2+ years’ experience in the field of clinical study administration required (CRO, Pharmaceutical, Biotech, Medical Device industry)
  • Good knowledge of the clinical study documentation and requirements for Study Master File
  • Experience with using electronic SMF
  • 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.
  • Previous experience in Quality Assurance / Quality Control is an advantage
  • Knowledge of other languages is an advantage