Responsibilities: Conduct a comprehensive review of study documents, including Protocol, CRF, and SAP. Create and assess statistical programs in SAS and/or R to produce CDISC-compliant SDTM and ADAM datasets. Execution of validation and...
Responsibilities: Have a strong understanding of CSV, as well as CAPA's, investigations, deviations. Help manage projects from concept through to completion, ensuring timely delivery of milestones and results. Utilize strong problem-sol...
Responsibilities: Provide clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects. Efficiently plan, coordinate, and deliver compl...
Responsibilities: Expertise in documenting / guiding various SDLC Deliverables including Requirements Specification/ User Stories, Criticality Assessment, Test Plan, Design Documentation, Validation Plan, Risk Assessment, Validation Strat...