Clinical Study Admininstrator (m/f)

REFERENZNUMMER:

245191/11

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

Clinical trial associate, Clinical trial assistant