Study Administrator in Neuchatel

veröffentlicht
Kontakt
Filipa Lessa, Basel Professionals Health Care & Life Sciences
Jobtyp
Temporary
jetzt bewerben

job details

veröffentlicht
Ort
Neuchatel, Neuenburg
Sektor
Gesundheitswesen
Jobtyp
Temporary
Referenznummer
11151
Kontakt
Filipa Lessa, Basel Professionals Health Care & Life Sciences
Telefon
058 201 55 50
jetzt bewerben

Stellenbeschreibung

 

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

o   2+ years’ experience in the field of clinical study administration required (CRO, Pharmaceutical, Biotech, Medical Device industry)

o   Good knowledge of the clinical study documentation and requirements for Study Master File

o   Experience with using electronic SMF

o   Fluent English (oral and written)

o   Strong interpersonal skills and strong team player

o   Good knowledge of MS Office Suite, capacity to learn the use of other IT tools.

o   Previous experience in Quality Assurance / Quality Control is an advantage

o   Knowledge of other languages is an advantage

 

We are looking forward to receiving your application:

  • your CV in English
  • latest Work Certificates
  • your Motivation Letter  
  • ID/passport copy
  • Copy of Work Permit

Apply now to be considered!

For more information and your application, please contact:

Filipa Lessa

Recruiter Randstad Professionals

filipa.lessa@randstad.ch or +41 58 201 55 60