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Senior Clinical Trial Scientist (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Cs, Sap
Projektbeschreibung
REFERENZNUMMER:
321096/11
IHRE AUFGABEN:
-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
IHRE QUALIFIKATIONEN:
-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
WEITERE QUALIFIKATIONEN:
Clinical trial assistant
321096/11
IHRE AUFGABEN:
-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
IHRE QUALIFIKATIONEN:
-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
WEITERE QUALIFIKATIONEN:
Clinical trial assistant
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, SAP Entwicklung