Business Unit Manager
+32 497 71 58 10
Site Management services provides Trial Co-ordination and Site Management services as primary point of contact between the sponsor and the investigational site. Services/deliverables include ensuring trial sites are inspection ready through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), applicable regulations from start-up through data-base lock. Further, services/deliverables will include pre-trial assessment, site selection, subject recruitment and retention planning, site initiation, monitoring and close-out. Partners with the Clinical Trial Assistant (CTA)/Investigator Document Assistant (IDA), Local Trial Manager (LTM) and Central Trial Manager (CTM)/Global Trial Manager (GTM) to ensure overall site management while performing trial related activities for assigned protocols.
- 2/4 years of relevant experience ( CRA or similar)
- Experience with early stages trials Phase II and III or similar
- Experience in pharma ( not only academia or hospital)
- Fluent in Dutch and/or French + English
- Available to travel 30-40%