Description
We are looking for a
Senior Clinical Trial Scientist (m/f)
Reference: -en
Start: ASAP
Duration: 12 MM+
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Erzeugnissen
Your tasks:
- Take responsibility for the creation and maintenance of protocols, including amendments, Clinical Study Report (CSR), Subjects' narratives, Core Informed Consent Form (CICF) as well as literature reviews
- Review the Data Review Manual, Statistical Analysis Plan (SAP), Dummy tables, Case Report Form (design, completion), External Service Providers' (ESP) user requirements and data transfer specifications (DTS), medical coding
- Scientific training of the Clinical Trial Team (CTT) members, Steering Committee (SC) management (including charter, independent data monitoring committee (IDMC) management (including charter, excluding medical monitoring)
- PD management, review of non-medical coding, filing of CS trial documentation
Your qualifications
- PhD, PharmD, DVM, MSc or equivalent degree in Biological Sciences as well as profound experience in clinical research in a clinical research organization (CRO) or a pharmaceutical company
- Experience in all key phases of a clinical trial (set up, run, closure) as well as participation in the creation the respective, required documentation (ICF,CRF; protocol (deviations), narrative)
- Good knowledge of regulatory requirements/ICH guidelines and an outstanding command of English in both verbal and written form
Skills:
- Clinical trial assistant