Clinical Scientist Consultant SME Level - Neurology *Pivotal Studies
Support the planning and execution of neurology clinical programs, including CIDP, through:
Review of adjudication charters, endpoint assessment manuals, and related operational plans
Identification of clinical trial execution risks, operational gaps, and potential barriers to enrollment, data quality, and study delivery
Review of study start-up, site activation, enrollment, monitoring, vendor oversight, and participant-retention strategies
Assessment of protocol operational feasibility and support for protocol development and pivotal-study planning
Review of clinical data, protocol deviations, missing data, and emerging study trends to identify potential quality or execution concerns
Evaluation of site and vendor performance, including escalation pathways, roles and responsibilities, and operational accountability
Support for development of risk-mitigation plans, issue-management processes, and corrective and preventive actions, as appropriate
Cross-functional collaboration with Clinical Development, Clinical Operations, Biometrics, Regulatory, Safety, and external vendors
Support for regulatory preparation and inspection- or submission-readiness activities
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