... company-sponsored GMA evidence generating studies projects Manages all medical aspects such as study document development and drives execution ... prospective and or retrospective study design and all stages of study conduct (Start- up, Execution, Analysis, ...
... deliverable quality for the pivotal studies, Integrated Summary of Efficacy (ISE) ... Report Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, ...
... manage, with limited direction, Biostatistics study activities assigned, to support non- ... Clinical Research Demonstrated expertise in study design, conduct and execution Excellent ...
... .The position holder will support study lead and partner with internal ... potential audits linked to assigned studies Vendor Oversight With supervision, responsible ...
... to best practice standard for study design and decision making to ... in vitro or in vivo studies when needed. Responsible for all ... vendors, to support ADME DMPK studies. PK PD support and use ...
... (s) (SAP) according to the study protocols, and also Table, Figures, ... the Statistical Report from the study results, with active collaborate in the revision of the the Clinical Study Report. His her contribution will ...
... by Global Oncology Medical Affairs Study Operations partners and propose mitigation ... Affairs interventional and non-interventional studies, including Ph 3b 4, EAP, ... external clinical collaboratins, and observational studies Ability to select the optimal ...
... by Global Oncology Medical Affairs Study Operations partners and propose mitigation ... Affairs interventional and non-interventional studies, including Ph 3b 4, EAP, ... clinical collaborations, and observat onal studies Prior experience working in an ...
... self, perform programmatic review of Study Date Tabulation Model (SDTM) and ... CDISC and submission requirement, review study submission data package and ensure ...
... all necessary regional HEOR & RWE studies and supports the development of ... endpoints for integration in pivotal studies. Ensures external view validation of ...