Clinical Research Scientist

Remote Position - Part-time as needed

Clinical Scientist Consultant SME Level - Neurology *Pivotal Studies

12 Months

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