Description
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